CLORALEN ANTIBACTERIAL WIPES- benzalkonium chloride cloth

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)

Available from:

Industrias Alen, S.A. de C.V.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Hand Sanitizer to help reduce bacteria on the skin.

Authorization status:

OTC monograph not final

Summary of Product characteristics

CLORALEN ANTIBACTERIAL WIPES- BENZALKONIUM CHLORIDE CLOTH
INDUSTRIAS ALEN, S.A. DE C.V.
_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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CLORALEN ANTIBACTERIAL WIPES 36 WET WIPES
DRUG FACTS
ACTIVE INGREDIENT
Benzalkonium Chloride 0.13%
PURPOSE
Antimicrobial
USE:
Hand Sanitizer to help reduce bacteria on the skin.
WARNINGS
For external use only.
WHEN USING THIS PRODUCT,
do not use in or near the eyes, in case of contact, rinse eyes
thoroughly with water.
STOP USING AND ASK A DOCTOR IF
Irritation or rash appears and lasts.
KEEP OUT OF REACH OF CHILDREN:
If swallowed, get medical help or contact a Poison Control Center
right away.
Children under 6 years of age should be supervised when using
CLORALENTM
ANTIBACTERIAL WIPES.
DIRECTIONS
Wet hands thoroughly with product and allow to dry.
INACTIVE INGREDIENTS
Aqua, Laurylamine Dipropylenediamine, Propylene Glycol USP,
Phenoxyethanol,
Fragrance, PEG-40 Hydrogenated Castor Oil, Glycerin, Sodium
Cocoamphoacetate, Isopropyl Alcohol, Citric Acid, Tetrasodium EDTA,
Laureth-7 Citrate.
PACKAGE LABELING:
CLORALEN ANTIBACTERIAL WIPES
benzalkonium chloride cloth
Industrias Alen, S.A. de C.V.
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:81350-002
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6JUD5X6Y)
BENZ ALKONIUM
CHLORIDE
1.3 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
N-(3-AMINOPROPYL)-N-DODECYL-1,3-PROPANEDIAMINE (UNII: PCJ6308JUE)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: