CLORALEN TM ANTIBACTERIAL WIPES- benzalkonium chloride liquid

CLORALEN TM ANTIBACTERIAL WIPES by

Drug Labeling and Warnings

CLORALEN TM ANTIBACTERIAL WIPES by is a Otc medication manufactured, distributed, or labeled by INDELPA, S.A DE C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Antibacterial

ACTIVE INGREDIENT

BENZALKONIUM, CHLORIDE 0.125%

INDICATIONS & USAGE

Hand sanitizer to help reduce bacteria on the skin

WARNINGS

For external use only.

DO NOT USE

If you are allergic to any of the ingredients

WHEN USING

Do not get into eyes.

If contact occurs, rinse throughly with water

STOP USE

If irritation or rash develops and continues for more than 72 hours

ASK DOCTOR

If irritation or rash develops and continues for more than 72 hours

KEEP OUT OF REACH OF CHILDREN

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

INSTRUCTIONS FOR USE

- wet hands throughly with product and allow to dry.

-discard wipe in trash receptacle after use. Do not flush

- chuldren under 6 years af age should be supervised whe using this product

INACTIVE INGREDIENT

water, propylene glycol USP, polysorbate 20, sodium cocoamphoacetate, fragrance, methylchloroisothiazolinone / methylisothiazolinone, aloe vera extract, tetrasodium EDTA, citric acid, acetate D alpha- tocopherol

DOSAGE & ADMINISTRATION

Topical admistration

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLORALEN TM ANTIBACTERIAL WIPES 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70697-802
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.125 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.01 mg  in 100 mg
EDETATE SODIUM (UNII: MP1J8420LU)	0.03 mg  in 100 mg
WATER (UNII: 059QF0KO0R)	98.567 mg  in 100 mg
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)	0.1 mg  in 100 mg
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.05 mg  in 100 mg
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.018 mg  in 100 mg
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)	0.1 mg  in 100 mg
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.3 mg  in 100 mg
SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)	0.2 mg  in 100 mg
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.05 mg  in 100 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70697-802-01	24 in 1 CASE	09/01/2020
1		0.375 mg in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/01/2020

Labeler - INDELPA, S.A DE C.V (811072487)

Registrant - INDELPA, S.A DE C.V (811072487)

Establishment
Name	Address	ID/FEI	Business Operations
INDELPA, S.A DE C.V		811072487	pack(70697-802) , manufacture(70697-802) , label(70697-802) , analysis(70697-802)