STMT SELF CARE SPA SET- alcohol gel
HORIZON GROUP USA, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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STMT Self Care Spa Set

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 Image

image description

STMT SELF CARE SPA SET
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80797-002
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:80797-002-01	28 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/07/2020

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

Labeler - HORIZON GROUP USA, INC. (029158008)