ANTISEPTIC HAND CLEANSING GEL- ethyl alcohol gel

Antiseptic Hand Cleansing Gel by

Drug Labeling and Warnings

Antiseptic Hand Cleansing Gel by is a Otc medication manufactured, distributed, or labeled by Playaction LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Alcohol 62%

PURPOSE

Purpose
Antiseptic

INDICATIONS & USAGE

Uses:

• Hand sanitizer to help decrease bacteria on the skin.
• Recommended for repeat use.

WARNINGS

Warnings: For external use only.

Flammable. Keep away from fire or flame.

Do not apply around eyes.

Do not use in ears or mouth.

STOP USE

Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. Children must be supervised in use of this product.

DOSAGE & ADMINISTRATION

Directions:

• Pump as needed into your palms and thoroughly spread on both hands.
  
• Rub into skin until dry.                                                                                                                                                                          

Other information:

• Store at 20 C - 25 C (68 F - 77 F)
• May discolor fabrics
  

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:Water, Glycerin, Propylene Glycol, Carbomer, Fragrance, Aminomethyl propanol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTISEPTIC HAND CLEANSING GEL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69246-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69246-001-03	87 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/24/2014

Labeler - Playaction LLC (078773816)