DEVOLVER HAND SANITIZER- alcohol gel

Devolver Hand Sanitizer by

Drug Labeling and Warnings

Devolver Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Devolver Cosmetics Co.,Ltd, Skin n Skin Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
ETHANOL 70%

INACTIVE INGREDIENT

Inactive ingredients
Water, Glycerin, Carbomer, Trolamine, Aloe Extract, Parsley Extract, Orange Oil, Limonene

PURPOSE

Purpose: ANTISEPTIC

WARNINGS

Warnings

For external use only. Flammable. Keep away from heat or flame
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Do not use
in children less than 2 months of age
on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

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

Uses

Uses
Hand sanitizer to help reduce bacteria that potentially can cause disease.

Directions

Directions
Wet hands thoroughly with product and allow to dry without wiping - For children under 6, use only under adult supervision.

Other information

Other information
Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

PACKAGE LABEL - Devolver Hand Sanitizer Gel 100mL

PACKAGE LABEL - Devolver Hand Sanitizer Gel 236mL

PACKAGE LABEL - Devolver Hand Sanitizer Gel 500mL

INGREDIENTS AND APPEARANCE

DEVOLVER HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75001-010
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
Trolamine (UNII: 9O3K93S3TK)
Aloe (UNII: V5VD430YW9)
Parsley (UNII: 58FMD0Q0EV)
ORANGE OIL (UNII: AKN3KSD11B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75001-010-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2020
2	NDC: 75001-010-02	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020
3	NDC: 75001-010-03	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/01/2020

Labeler - Devolver Cosmetics Co.,Ltd (695733244)

Registrant - Devolver Cosmetics Co.,Ltd (695733244)

Establishment
Name	Address	ID/FEI	Business Operations
Skin n Skin Co., Ltd.		631090037	manufacture(75001-010)