CAREN HAND SANITIZER ANTISEPTIC- benzalkonium chloride gel

Caren Hand Sanitizer Antiseptic by

Drug Labeling and Warnings

Caren Hand Sanitizer Antiseptic by is a Otc medication manufactured, distributed, or labeled by Caren Products, LLC, Cosco International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium Chloride....................Purpose: Antimicrobial and First Aid Antiseptic

Purpose

Antimicrobial and First Aid Antiseptic

Uses

• For hand sanitizing to decrease bacteria on the skin.  Recommended for repeated use.  
• For wound sanitizing to help prevent bacterial contamination in cuts, scrapes, burns, lacerations, and sking infections.

Warnings

For external use only.

WHEN USING

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

STOP USE

Discontinue use if irratation or redness develops.  If condition persists for more than 72 hours consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.
• Antiseptic: Apply to cuts, scrapes, and burns 3 times a day after cleaning.  Allow to dry.

Inactive ingredients

Aloe, Carbomer, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Purified Water

Package Label - Principal Display Panel

Package Label - Principal Display Panel

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

CAREN HAND SANITIZER ANTISEPTIC 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77009-0420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0013 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALOE (UNII: V5VD430YW9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77009-0420-1	0.059 kg in 1 TUBE; Type 0: Not a Combination Product	05/28/2020
2	NDC: 77009-0420-2	0.118 kg in 1 TUBE; Type 0: Not a Combination Product	05/28/2020
3	NDC: 77009-0420-3	0.948 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/28/2020

Labeler - Caren Products, LLC (932901676)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc.		016433141	manufacture(77009-0420)