RID Lice Treatment Complete Kit

RID LICE TREATMENT COMPLETE KIT- rid lice treatment complete kit Bayer HealthCare LLCDisclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if theycomply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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RID Lice Treatment Complete KitDrug Facts

ShampooActive ingredients

Piperonyl butoxide (4%)

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Purpose

Lice treatment

UsesUses treats head, pubic (crab), and body lice

Warnings

For external use onlyDo not use· near the eyes

· inside the nose, mouth, or vagina

· on lice in eyebrows or eyelashes. See a doctor if lice are present

in these areas.

· if you have ever had an allergic reaction to this product or any of its

ingredients

Ask a doctor before use if you are allergic to ragweed. May cause breathing difficulty or an asthmaticattack.

When us ing this product● keep eyes tightly closed and protect eyes with a washcloth or

towel

● if product gets in eyes, flush with water right away

● scalp itching or redness may occur

Stop use and ask a doctor if● breathing difficulty occurs

● eye irritation occurs

● skin or scalp irritation continues or infection occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center rightaway.

Directions

● Important: Read warnings before use

Adults and children 2 years and over:

Inspect

● check each household member with a magnifying glass in bright

light for lice/nits (eggs)

● look for tiny nits near scalp, beginning at back of neck and

behind ears

● examine small sections of hair at a time

● unlike dandruff which moves when touched, nits stick to the hair

● if either lice or nits are found, treat with this product

Treat

● apply thoroughly to DRY HAIR or other affected area. For head

lice, first apply behind ears and to back of neck.

● allow product to remain for 10 minutes, but no longer

● use warm water to form a lather, shampoo, then thoroughly

rinse

● for head lice, towel dry hair and comb out tangles

Remove lice and their eggs (nits)

● use a fine-tooth or special lice/nit comb. Remove any remaining

nits by hand (using a throw-away glove).

● hair should remain slightly damp while removing nits

● if hair dries during combing, dampen slightly with water

● for head lice, part hair into sections. Do one section at a time

starting on top of head. Longer hair may take 1 to 2 hours.

● lift a 1- to 2-inch wide strand of hair. Place comb as close to

scalp as possible and comb with a firm, even motion away from

scalp.

● pin back each strand of hair after combing

● clean comb often. Wipe nits away with tissue and discard in a

plastic bag. Seal bag and discard to prevent lice from coming

back.

● after combing, thoroughly recheck for lice/nits. Repeat combing

if necessary.

● check daily for any lice/nits that you missed

● a second treatment must be done in 7 to 10 days to kill any

newly hatched lice

● if infestation continues, see a doctor for other treatments

Children under 2 years : ask a doctor

Other informationOther information

● keep carton for important product information

● see Consumer Information Insert for additional information

● avoid excessive heat

Inactive ingredients ammonium laureth sulfate, dehydrated alcohol, fragrance, isopropyl alcohol, PEG-25 hydrogenated castor oil, polyquaternium-10, purified water

Questions or CommentsQuestions or comments? 1-800-RID-LICE (1-800-743-5423) (Mon – Fri 9AM – 8PM EST)www.ridlice.com

Lice & Egg Comb Out Spray

UseRID® Lice & Egg Comb-Out Spray detangles hair in order to make lice and egg comb-out easier.

For external use only. Keep out of reach of children. Avoid contact with eyes . Do not use if youhave ever had an allergic reaction to this product or any of its ingredients .Directions For Use● Before us ing, read Consumer Information Insert for complete directions .● Use AFTER shampooing with RID® Lice Killing Shampoo.● Towel dry hair. Apply a small amount of RID® Lice & Egg Comb-Out Spray and use a wide-toothed

comb to remove any tangles.

● Comb out the dead lice, eggs, and nits, one small section at a time, with the enclosed RIDvantage®Jr.Lice Comb. (See insert for additional combing instructions). This s tep is very important.● Use additional RID® Lice & Egg Comb-Out Spray to remove tangles, if needed, during the comb-out

process.

● After you have combed entire head, rinse hair thoroughly with warm water. Disinfect combs with hotwater (130ºF).

Other Information● It is important to wash in hot water (130ºF) all clothing, bedding, towels, and hair products (combs,

brushes) used by infested persons in the two days prior to treatment.

● Dry clean non-washable fabrics.

● To eliminate infestation of furniture and bedding that cannot be washed or dry cleaned, a multi-uselice

spray such as RID® Home Lice, Bedbug & Dust Mite Spray may be used.

● RID® Lice & Egg Comb-Out Spray does not kill lice or their eggs . Use this product only aftertreating

with RID® Lice Killing Shampoo.

● Store in a cool, dry place. Keep from freezing.

Questions?1-800-RID-LICE (1-800-743-5423)

Consumer Information

RID

LICE TREAMENT

COMPLETE KIT

LICE TREATMENT

Easy-to-Follow 3-step Process

Instructions inside1. Treat2. Remove3. Control

24/7SUPPORTCALL AN EXPERT1-800-RID-LICEHOW--TO VIDEOSTRATAMIENTO DE PIOJOS--KIT COMPLETO

Se incluyen instrucciones en espanol

SHAMPOO NET WT. 4 FL OZ (118 mL)

COMB-OUT SPRAY NET WT. 2 FL OZ (59 mL)

RID® HOME LICE, BEDBUG & DUST MITE SPRAY

NET WT. 3 oz (851 g)

1 PATENTED® RID LICE COMB

KEEP OUT OF REACH OF CHILDREN

CAUTIONSee Back Panel for Additional Precautions

RID LICE TREATMENT COMPLETE KIT rid lice treatment complete kit kit

Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:0 28 0 -9 0 50

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:0 28 0 -9 0 50 -0 1 1 in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct 0 5/0 9 /20 16

Quantity of PartsPart # Package Quantity Total Product QuantityPa rt 1 1 BOTTLE 118 mL

Pa rt 2 1 BOTTLE 59 mL

Part 1 of 2

RID LICE KILLING piperonyl butoxide, pyrethrum extract shampoo

Product InformationRoute of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

PYRETHRUM EXTRACT (UNII: ZUM0 6 L9 0 GV) (PYRETHRUM EXTRACT -UNII:ZUM0 6 L9 0 GV)

PYRETHRUMEXTRACT

3.3 mg in 1 mL

PIPERO NYL BUTO XIDE (UNII: LWK9 1TU9 AH) (PIPERONYL BUTOXIDE -UNII:LWK9 1TU9 AH)

PIPERONYLBUTOXIDE 40 mg in 1 mL

Inactive IngredientsIngredient Name Strength

WATER (UNII: 0 59 QF0 KO0 R)

PO LYQ UATERNIUM-10 ( 10 0 0 MPA.S AT 2 %) (UNII: GMR4PEN8 PK)

PEG-2 5 HYDRO GENATED CASTO R O IL (UNII: 0 ZNO9 PJJ9 J)

Product CharacteristicsColor white (Clear) Score

Shape Siz e

Flavor Imprint Code

Contains

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph fina l part358 G 0 5/0 9 /20 16

Part 2 of 2

LICE AND EGG COMB OUT other hair preparations spray

Product InformationRoute of Adminis tration TOPICAL

Bayer HealthCare LLC

Other IngredientsIngredient Kind Ingredient Name Quantity

INGR WATER (UNII: 0 59 QF0 KO0 R)

INGR PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

INGR AMO DIMETHICO NE ( 13 0 0 CST) (UNII: 3V7U6 36 DWN)

INGR SEC-TRIDECETH-12 (UNII: 6 WTE57JSWS)

INGR METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)

INGR PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

INGR METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

INGR GLYCERIN (UNII: PDC6 A3C0 OX)

INGR PANTHENO L (UNII: WV9 CM0 O6 7Z)

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 59 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct


Co smetic 0 5/0 9 /20 16


OTC mo no graph fina l part358 0 5/0 9 /20 16

Labeler - Bayer HealthCare LLC (112117283)

Revised: 8/2019

Documents

RID Lice Treatment Complete Kit