DEVOLVER PREMIUM TISSUE- alcohol liquid

Devolver Premium Tissue by

Drug Labeling and Warnings

Devolver Premium Tissue 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 75%

Purpose

Antiseptic

Uses

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

Water, Glycerin, Hydroxy Acetophenone, Cetylpyridinium Chloride, Citric Acid, Butylene Glycol, Aloe ferox leaf extract, Fragrance (Lime)

Package Label

INGREDIENTS AND APPEARANCE

DEVOLVER PREMIUM TISSUE 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75001-204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE FEROX LEAF (UNII: 0D145J8EME)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
LIME (CALCIUM OXIDE) (UNII: C7X2M0VVNH)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75001-204-01	100 g in 1 POUCH; Type 0: Not a Combination Product	05/17/2020
2	NDC: 75001-204-02	100 g in 1 POUCH; Type 0: Not a Combination Product	05/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/17/2020

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(75001-204)