DEVOLVER PREMIUM GEL- alcohol gel

Devolver Premium Gel by

Drug Labeling and Warnings

Devolver Premium Gel by is a Otc medication manufactured, distributed, or labeled by Devolver Cosmetics Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Use

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

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

keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water.

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.

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

Directions

Wet hands thoroughly with product and allow to dry without wiping.

For children under 6, use only under adult supervision.

Other information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Purified Water, Glycerin, Carbomer, Fragrance, Trolamine, Aleo Extract(09), Parsley Extract

Package Label

INGREDIENTS AND APPEARANCE

DEVOLVER PREMIUM GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75001-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70.00075 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PETROSELINUM CRISPUM (UNII: 1WZA4Y92EX)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75001-201-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
2	NDC: 75001-201-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
3	NDC: 75001-201-03	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/08/2020
4	NDC: 75001-201-04	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/08/2020
5	NDC: 75001-201-05	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/08/2020

Labeler - Devolver Cosmetics Co., Ltd (695733244)

Registrant - Devolver Cosmetics Co., Ltd (695733244)

Establishment
Name	Address	ID/FEI	Business Operations
Devolver Cosmetics Co., Ltd		695733244	manufacture(75001-201)