HAND SANITIZER- ethyl alcohol 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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47993-327

Active ingredients

Ethanol 64% w/w

Antiseptic

Uses:

Warnings:

FLAMMABLE. Keep away from fire or flame

For external use only.

When using this product

Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Directions:

Other information:

Inactive ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #5, Fragrance, Glycereth-2 Cocoate, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Triethanolamine, Water

image of hand sanitizer 532mlimage of hand sanitizer 800mlimage of hand sanitizer 118ml

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-327
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL64 g  in 112 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47993-327-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2021
2NDC:47993-327-02532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/16/2021
3NDC:47993-327-03800 mL in 1 BAG; Type 0: Not a Combination Product06/16/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/16/2021
Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)

Revised: 6/2021
Document Id: c4f14787-9e1d-ffbb-e053-2a95a90a89b8
Set id: c6fae508-d307-438e-915e-7ecdc5844e3d
Version: 1
Effective Time: 20210617
 
NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD