ANTIMICROBIAL WIPES ALCOHOL FREE- benzalkonium chloride cloth

Antimicrobial Wipes Alcohol Free by

Drug Labeling and Warnings

Antimicrobial Wipes Alcohol Free by is a Otc medication manufactured, distributed, or labeled by Valley of the Sun Cosmetics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

Antimicrobial Wipes are used to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only.

Do not Use

• in children less than 2 years of age, do not use as baby wipe.
• 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 doctor

If irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children

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

Directions

• To dispense, lift cover, remove seal, pull center sheet from roll, twist to a point and feed through dispenser hole in cover. Keep lid closed to prevent moisture loss.
• Open and unfold wipe
• Thoroughly wipe hands, fingers and wrists. Be sure to use the entire wipe. Allow to dry.
• For dirty hands, use first wipe to clean hands, then discard wipe; sanitize with the second wipe.
• Discard after single use
• Supervise children under 2 years of age when using this product to avoid swallowing

Other information

• Store between 15-30ºC (59-86°F)
• Avoid freezing and excessive heat above 40ºC(104°F)

Inactive ingredients

Water, Glycerin, Aloe barbadensis (aloe vera) leaf extract, Hydrogen Peroxide, Tocopheryl Acetate (Vitamin E), PEG-60 Hydrogenated Castor Oil, Propylene Glycol, Phenoxyethanol

Label and product picture

80 wipes in 1 canister, NDC: 76523-094-80

INGREDIENTS AND APPEARANCE

ANTIMICROBIAL WIPES ALCOHOL FREE 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76523-094
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 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	97.14 g  in 100 g
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.15 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	1.45 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.3 g  in 100 g
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)	0.4 g  in 100 g
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.3 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.01 g  in 100 g

Product Characteristics
Color	white (Canister white with blue cap)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76523-094-80	100 g in 1 CANISTER; Type 0: Not a Combination Product	11/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/12/2020

Labeler - Valley of the Sun Cosmetics LLC (176470664)

Registrant - Valley of the Sun Cosmetics LLC (176470664)

Establishment
Name	Address	ID/FEI	Business Operations
Valley of the Sun Cosmetics LLC		176470664	manufacture(76523-094)