Drug Labeling and Warnings

Drug Details

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HAND SANITIZER- hand sanitizer gel 
NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredients--------------purpose

Ethyl Alcohol 62%------------antiseptic

Uses:
For hand sanitizing to reduce bacteria on the skin.

Warnings:

Flammable: Keep away from fire or flame.For external use only. Keep out of reach of choldren. Keep out of reach of eyes. Do not inhale or ingest. Stop use and ask doctor if irritation or redness develops.

Directions:

Squeeze small amount in your palm and briskly rub hands together until dry.

Other Information

Do not store above 110F(43C) May discolor certain fabric or surfaces. Harmful to wood finishes and plastics.

Keep out of reach of children

Inactive ingredients

Water,Carbomer 940,Triethanolamine,Glycerin,Aloe Barbadensis

235ml75ml

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 47993-208
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W) 3 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 12 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 20 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 47993-208-0175 mL in 1 BOTTLE; Type 0: Not a Combination Product03/17/2020
2NDC: 47993-208-02237 mL in 1 BOTTLE; Type 0: Not a Combination Product03/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/17/2020
Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
Establishment
NameAddressID/FEIBusiness Operations
NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.,LTD TRADING CO.,LTD544493972manufacture(47993-208)

Revised: 3/2020
 
NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD


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