INSTANT HAND SANITIZER- ethyl alcohol gel

Instant Hand Sanitizer by

Drug Labeling and Warnings

Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Kentron Healthcare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Chloroxylenol 0.52%

PURPOSE

Purpose

Antiseptic

WARNINGS

Warnings: For external use only.

Do not apply around eyes.

Do not use in ears or mouth.

When using this products, avoid contact with eyes. In case of contact, flush eyes with water.

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.

INACTIVE INGREDIENT

Inactive Ingredients:Water, Cetearyl Alcohol, Mineral Oil, Petrolatum, Stearic Acid, DMDM Hydantoin, Ceteareth-20, Triethanolamine, Carbomer, Methyl Pareben, Propyl Paraben, Fragrance, Disodium EDTA, Aloe Barbadensis Leaf Juice

INDICATIONS & USAGE

Uses: Hand sanitizer to help decrease bacteria on the skin when water, soap & towel are not available. Recommended for repeated use.

STORAGE AND HANDLING

Other information: Do not store in temperature above 118 F.

STOP USE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69556-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLPARABEN (UNII: A2I8C7HI9T)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
STEARIC ACID (UNII: 4ELV7Z65AP)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MINERAL OIL (UNII: T5L8T28FGP)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69556-002-01	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/04/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/04/2017

Labeler - Kentron Healthcare, Inc. (618825723)