Mint Antibacterial Hand Soap

Hand wash by

Drug Labeling and Warnings

Hand wash by is a Otc medication manufactured, distributed, or labeled by Absara Cosmetics S.A.P.I DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND WASH- benzalkonium chloride soap 
Absara Cosmetics S.A.P.I 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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Mint Antibacterial Hand Soap

Active Ingredient

Benzalkonium chloride 0.13%

Purpose

Antimicrobial

Use

For washing to decrease bacteria on the skin

Warnings

For external use only.

When using this product

• avoid contact with eyes.  In case of eye contact, flush with water.

Stop use and ask a doctor if

• irritation or redness develops

Keep out of reach of children

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

Directions

Wet hands with water, apply soap and rub for 20 seconds and rinse.

Inactive ingredients

Water, sodium laureth sulfate, cocamidopropyl betaine, sodium chloride, glycerin, polyquaternium –7, fragance, DMDM hydantoin, iodopropynyl butylcarbamate, butylene glycol, chamomilla recutita extract, aloe barbadensis extract, disodium EDTA, limonene, citric acid, blue 1 (CI 42090), yellow 5 (CI 19140).

Principal Display Panel

HAND WASH 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70956-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70956-100-50	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/31/2020	07/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/28/2015	07/01/2022

Labeler - Absara Cosmetics S.A.P.I DE C.V. (816161236)

Registrant - Absara Cosmetics S.A.P.I DE C.V. (816161236)

Establishment
Name	Address	ID/FEI	Business Operations
Absara Cosmetics S.A.P.I DE C.V.		816161236	manufacture(70956-100)

Revised: 9/2022

Document Id: 53e38101-ffbd-4b38-b37e-b2c6ba26f46e

34390-5

Set id: dbba1f58-3e63-4caf-bac3-22fbe29fabdc

Version: 2

Effective Time: 20220916