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HAND SANITIZER- alcohol gel ningbo fareas t industry co.,ltdReference Label Set Id: a68674ba-455a-4d63-e053-2a95a90aed00 Disclaimer: 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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alcohol 75% v/v purpose :antiseptic
alcohol 70% v/v purpose :antiseptic
alcohol 60% v/v purpose :antiseptic
to help reduce bacteria that potentially can cause disease.for use when soap and water are not available
for external use only,flammable,keep away from heat or flame
. in children less than 2 months of age
.on open skin wounds
when using this product keep out of eyes,ears,and mouth in case of contact with eyes,rinse eyesthorough with water stop use and ask a doctor if irritation or rash occurs,these may be signs of a serious condition. keep out of reach of children,if swallowed,get medical help or contact a poison control center rightaway.
stop use and ask a doctor if irriation or rash occurs,these may be signs of a serious condition
keep out of reach of children ,if swallowed, get medical help or contact a posion control center rightaway
place enough product on hands to cover all surface,rub hands together until dry supervise children under 6 years when using this product to avoid swallowing
package label principal display panel
75% alcohol concent
1000ml NDC: 78623-375-01
500ml NDC: 78623-375-02
237ml NDC: 78623-375-03
100ml NDC: 78623-375-04
60ml NDC: 78623-375-05
30ml NDC: 78623-375-06
70% alcohol concent
1000ml NDC: 78623-370-01
500ml NDC: 78623-370-02
237ml NDC: 78623-370-03
100ml NDC: 78623-370-04
60ml NDC: 78623-370-05
30ml NDC: 78623-370-06
60% alcohol concent
1000ml NDC: 78623-360-01
500ml NDC: 78623-360-02
237ml NDC: 78623-360-03
100ml NDC: 78623-360-04
60ml NDC: 78623-360-05
30ml NDC: 78623-360-06
HAND SANITIZER alcohol gel
Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:78 6 23-370
Route of Adminis tration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength
ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M) ALCOHOL 70 mL in 10 0 mL
Inactive IngredientsIngredient Name Strength
WATER (UNII: 0 59 QF0 KO0 R)
TRO LAMINE (UNII: 9 O3K9 3S3TK)
HYDRO GEN PERO XIDE (UNII: BBX0 6 0 AN9 V)
GLYCERIN (UNII: PDC6 A3C0 OX)
CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)
Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:78 6 23-370 -0 1 10 0 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 4/20 21
2 NDC:78 6 23-370 -0 2 50 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 4/20 21
3 NDC:78 6 23-370 -0 3 237 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 4/20 21
4 NDC:78 6 23-370 -0 4 10 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 4/20 21
5 NDC:78 6 23-370 -0 5 6 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 4/20 21
6 NDC:78 6 23-370 -0 6 30 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 4/20 21
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph no t fina l part333A 12/31/20 20
HAND SANITIZER alcohol gel
Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:78 6 23-375
Route of Adminis tration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength
ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M) ALCOHOL 75 mL in 10 0 mL
Inactive IngredientsIngredient Name Strength
CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)
WATER (UNII: 0 59 QF0 KO0 R)
TRO LAMINE (UNII: 9 O3K9 3S3TK)
GLYCERIN (UNII: PDC6 A3C0 OX)
HYDRO GEN PERO XIDE (UNII: BBX0 6 0 AN9 V)
Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:78 6 23-375-0 1 10 0 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 4/20 21
2 NDC:78 6 23-375-0 2 50 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 4/20 21
3 NDC:78 6 23-375-0 3 237 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 4/20 21
4 NDC:78 6 23-375-0 4 10 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 4/20 21
5 NDC:78 6 23-375-0 5 6 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 4/20 21
6 NDC:78 6 23-375-0 6 30 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 4/20 21
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph no t fina l part333A 0 1/0 4/20 21
HAND SANITIZER alcohol gel
Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:78 6 23-36 0
Route of Adminis tration TOPICAL
ningbo fareast industry co.,ltd
Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength
ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M) ALCOHOL 75 mL in 10 0 mL
Inactive IngredientsIngredient Name Strength
GLYCERIN (UNII: PDC6 A3C0 OX)
TRO LAMINE (UNII: 9 O3K9 3S3TK)
HYDRO GEN PERO XIDE (UNII: BBX0 6 0 AN9 V)
CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)
WATER (UNII: 0 59 QF0 KO0 R)
Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:78 6 23-36 0 -0 1 10 0 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 4/20 21
2 NDC:78 6 23-36 0 -0 2 50 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 4/20 21
3 NDC:78 6 23-36 0 -0 3 237 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 4/20 21
4 NDC:78 6 23-36 0 -0 4 10 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 4/20 21
5 NDC:78 6 23-36 0 -0 5 6 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 4/20 21
6 NDC:78 6 23-36 0 -0 6 30 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 4/20 21
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph no t fina l part333A 0 1/0 4/20 21
Labeler - ningbo fareas t indus try co.,ltd (554535808)
Revised: 1/2021
