HAND SANITIZER- alcohol gel
Jiangsu Ouyali Daily Cosmetic 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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Jiangsu Ouyali Daily Cosmetic Co., Ltd.
Hand Sanitizer 29ml 76719-015-01

Active Ingredient(s)

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce germs on the skin.

Warnings

For external use only.
Flammable: Keep away from heat or flame.

Do not use

in children less than 2 months of age
on open skin wounds

When using this product: avoid contact with eyes. lf contact occurs, rinse thoroughly with water.

Stop using and ask a doctor if irritation or redness develops and lasts.

Keep out of reach of children: ln case of accidental ingestion, get medical help or contact a poison control center immediately.

Directions

Squeeze a significant amount in your palm and rub hands until fully dry.
Rinse free.

Other information

Store below 110 °F（43° C).

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl propanol, Aloe Barbadensis leaf Juice, Denatonium benzoate, Fragrance, Glycerin, Maltodextrin, Propylene Glycol, Tocopheryl Acetate, Water.

Package Label - Principal Display Panel

29 mL NDC: 76719-015-01 29ml label_1 29ml label_2

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76719-015
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76719-015-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/26/2020

Labeler - Jiangsu Ouyali Daily Cosmetic Co., Ltd. (542920070)

Name	Address	ID/FEI	Business Operations
Establishment
WESSCO International		118553619	label(76719-015)

Name	Address	ID/FEI	Business Operations
Establishment
Jiangsu Ouyali Daily Cosmetic Co., Ltd.		542920070	manufacture(76719-015)

Jiangsu Ouyali Daily Cosmetic Co., Ltd. Hand Sanitizer 29ml 76719-015-01