HAND SANITIZER- hand sanitizer gel
Taizhou Huangyan Delishi Daily Necessity 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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HAND SANITIZER

Active Ingredient(s)

Ethyl Alcohol 62% v/v

Purpose

Antiseptic

Use

To help reduce bacteria and germs on the skin

Warnings

Do not use

In children less than 2 month of age. On open skin wounds

If irritation or rash occurs. These may be signs of a serious condition.

If swallowed, get medical hep or contact a Poison Control Center right away.

Directions

Place enough product in palm to cover hands and Rub hands together briskly until dry.

Children under 6,use only under adult suoervision.

Not recommended for infants.

Other information

Inactive ingredients

Water (Aqua), Carbomer, Glycerol, Triethanolamine(TEA), Fragrance

Package Label - Principal Display Panel

HAND SANITIZER
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76681-012
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)
CARBOMER 934 (UNII: Z135WT9208)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76681-012-05	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:76681-012-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC:76681-012-03	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC:76681-012-04	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC:76681-012-02	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC:76681-012-06	503 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC:76681-012-07	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

Labeler - Taizhou Huangyan Delishi Daily Necessity Co., Ltd. (527795950)

Name	Address	ID/FEI	Business Operations
Establishment
Taizhou Huangyan Delishi Daily Necessity Co., Ltd.		527795950	manufacture(76681-012)