CLEAN HANDS ANTIBACTERIAL HAND SANITIZER- ethyl alcohol gel
ENCHANTE ACCESSORIES INC.

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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Active Ingredient

Ethyl Alcohol 75%

Purpose

Antiseptic

Use

■ Hand sanitizer to help decrease bacteria on the skin
■When water, soap & towel are not available.
■Recommended for repeated use,

WARNINGS

For external use only■ Flammable
Keep away from fire or flame
Do not apply around eyes. Do not use in ears & mouth.
When using this product. avoid contact with eyes.
In case of contact flush eyes with water
Stop use and ask a doctor it redness or irritation
develop and persist for more than 72 hours

keep out of reach of children

Keep out of reach of children. Children must be supervised in use of this product

Directions

Pump as needed into your palms and thoroughly
spread on both hands. Rub into skin until dry
Other Information Store at 20C(88" to 77"F)
May discolor fabrices

Inactive ingredients

Water, Glycerin, Aloe barbadensis leaf extract, Carbomer, Tocopheryl Acetate, Triethanolamine

image description

CLEAN HANDS ANTIBACTERIAL HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50563-195
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 934 (UNII: Z135WT9208)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50563-195-01	200 in 1 CARTON	05/03/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:50563-195-02	150 in 1 CARTON	05/03/2020
2		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:50563-195-03	100 in 1 CARTON	05/03/2020
3		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:50563-195-04	24 in 1 CARTON	05/03/2020
4		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:50563-195-05	20 in 1 CARTON	05/03/2020
5		500 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:50563-195-06	18 in 1 CARTON	05/03/2020
6		1000 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC:50563-195-07	4 in 1 CARTON	05/03/2020
7		3780 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC:50563-195-08	4 in 1 CARTON	05/03/2020
8		5000 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	05/03/2020

Labeler - ENCHANTE ACCESSORIES INC. (186050696)

Name	Address	ID/FEI	Business Operations
Establishment
Hangzhou Huiji Biotechnology Co., Ltd.		526893497	manufacture(50563-195)