CARE ON HAND SANITIZER GEL- alcohol gel

CARE ON HAND SANITIZER Gel by

Drug Labeling and Warnings

CARE ON HAND SANITIZER Gel by is a Otc medication manufactured, distributed, or labeled by WELCRON HEALTHCARE CO., LTD, Devolver Cosmetics Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ethyl Alcohol 70%

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria on the skin.

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

• Put enough product in your palm to cover hands and rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using care on Hand Sanitizer gel.

Other information

• Store below 33.8-86F(1-30C)
• May discolor certain fabrics or surfaces.

Inactive ingredients

Water, Glycerin, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Extract, Rosemary Extract

Package Label

INGREDIENTS AND APPEARANCE

CARE ON HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70416-2001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
LICORICE (UNII: 61ZBX54883)
ROSEMARY (UNII: IJ67X351P9)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70416-2001-1	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/28/2020
2	NDC: 70416-2001-2	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/28/2020

Labeler - WELCRON HEALTHCARE CO., LTD (688301944)

Registrant - Devolver Cosmetics Co., Ltd (695733244)

Establishment
Name	Address	ID/FEI	Business Operations
Devolver Cosmetics Co., Ltd		695733244	manufacture(70416-2001)