HAND SANITIZER- ethyl alcohol gel
Yiwu Jiefei Daily Chemicals 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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73946-002 Hand Sanitizer

Active Ingredient(s)

Isopropyl Alcohol 62% v/v. Purpose: Antimicarobial

Purpose

Antimicrobial

Use

Kills 99.9% of germs on the skin.

Warnings

Warnings: For extermnal use only. Flammable.
Keep away from heat and flame.
When using this product: avoid contact with face, eyes,
and broken skin. In case of eye contact, flush with plenty
of water and seek medical advice. Stop use and ask a
doctor if rritation or redness develops.
Keep out of reach of children. .
If swallowed, get medical help or contact a
Poison Control Center.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

Directions

Directions: Wet hands thoroughly and rub into skin until
dry. Children under 6 years of age should be supervised
by an adult when using this product.

Inactive ingredients

Inactive Ingredients: Water, Glycerine,
Carbomer, VE, Flavor

Package Label - Principal Display Panel

HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73946-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 934 (UNII: Z135WT9208)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73946-002-01	24 in 1 CARTON	03/30/2020
1		2 in 1 CONTAINER
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:73946-002-02	96 in 1 CARTON	03/30/2020
2		24 in 1 BOX
2		2 in 1 CONTAINER
2		10 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:73946-002-03	96 in 1 CARTON	03/30/2020
3		24 in 1 BOX
3		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:73946-002-04	24 in 1 CARTON	03/30/2020
4		2 in 1 CONTAINER
4		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:73946-002-05	24 in 1 CARTON	03/30/2020
5		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:73946-002-06	24 in 1 CARTON	03/30/2020
6		500 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC:73946-002-07	72 in 1 CARTON	03/30/2020
7		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC:73946-002-08	12 in 1 CARTON	03/30/2020
8		1000 mL in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - Yiwu Jiefei Daily Chemicals Co.,Ltd. (542996874)

Name	Address	ID/FEI	Business Operations
Establishment
Yiwu Jiefei Daily Chemicals Co.,Ltd.		542996874	manufacture(73946-002)