BENZALKONIUM CHLORIDE- antibacterial hand wipes cloth

Benzalkonium Chloride by

Drug Labeling and Warnings

Benzalkonium Chloride by is a Otc medication manufactured, distributed, or labeled by PreCare Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

• Hand sanitizer to help reduce bacteria
• For use when soap and water are not available

Warnings

For external use only.

Do not use

• in children less than 2 months old.
• 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 serious condition.

Keep out of reach of children.

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

Directions

• Apply to hands, allow to air dry without wiping.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store in a cool, dry place, between 15°-30°C (59°F-86°F).
• Avoid freezing and excessive heat above 40°C (104°F).

Inactive ingredients

Aloe Barbadensis Leaf Extract, Citric Acid, Decyl Glucoside, Disodium EDTA, Fragrance, Phenoxyethanol, Potassium Sorbate, Purified Water, Sodium Benzoate

Questions?

call 718-975-2586

Principal Display Panel

INGREDIENTS AND APPEARANCE

BENZALKONIUM CHLORIDE 
antibacterial hand wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53118-140
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53118-140-04	1400 in 1 CONTAINER; Type 0: Not a Combination Product	02/14/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/14/2022

Labeler - PreCare Corp. (858442403)