ISM BE-YOU-TIFUL SELF CARE STUDIO- ethyl alcohol gel

ISM BE-YOU-TIFUL SELF CARE STUDIO by

Drug Labeling and Warnings

ISM BE-YOU-TIFUL SELF CARE STUDIO by is a Otc medication manufactured, distributed, or labeled by HORIZON GROUP USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ethyl Alcohol

Purpose

Antiseptic

Warnings

• For external use only. Flammable. Keep away from heat or flame.
• Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
• 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.

Uses

• Hand Sanitizer to help reduce bacteria that potentially can cause disease.
• For use when soap and water are not available.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Keep out of reach of children.

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

Other Information 

Store between 15-30C (59-86F); Avoid freezing or excessive heat above 40C (104F)

Inactive Ingredient

Water/Aqua/Eau,Glycerin,Carbomer,Triethanolamine,parfum,Denatonium benzoate,Red 27 (CI 45410).

Product Label

INGREDIENTS AND APPEARANCE

ISM BE-YOU-TIFUL SELF CARE STUDIO 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80797-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80797-001-01	28 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/07/2020

Labeler - HORIZON GROUP USA, INC. (029158008)