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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47993-243

Active ingredients

Ethyl Alcohol 65%

Antiseptic

Warnings:

Flammable. Keep away from fire or flame. For external use only. Keep out of reach of children. Keep out of reach of eyes.

Keep out of reach of children.

Uses：

For hand sanitizing to readuce bacteria on the skin.

Directions:

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

Inactive Ingredients:

Water,Carbomer 940,Triethanolamine,Glycerin,Aloe Barbadensis Leaf Juice,Vitamin E

100ml

237ml

1000ml

HAND SANITIZER
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47993-243
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 g in 112 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER 940 (UNII: 4Q93RCW27E)	12 g in 112 mL
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)
WATER (UNII: 059QF0KO0R)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)	2 g in 112 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:47993-243-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020
2	NDC:47993-243-02	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020
3	NDC:47993-243-03	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/27/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/27/2020

Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)

Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)

Revised: 11/2020

Document Id: b343b992-d68a-5fa8-e053-2995a90a7813

Set id: a4477241-b361-6699-e053-2a95a90aa515

Version: 5

Effective Time: 20201104

NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD