PRO-SANITIZE- benzalkonium chloride liquid

Pro-Sanitize by

Drug Labeling and Warnings

Pro-Sanitize by is a Otc medication manufactured, distributed, or labeled by Clean Beauty Concepts. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

The sanitizer wipes is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

1. Benzalkonium Chloride (
2. Glycerol
3. Hydrogen peroxide
4. Sterile distilled water or boiled cold water.
5. Fragrance (Parfum)
6. Aloe vera leaf extract
7. Vitamin E

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Use

Antiseptic wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

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 a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

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 holde 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 6 years of age when using this product to avoid swallowing

Other information

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

Inactive ingredients

water(aqua), glycerin, hydrogen peroxide, fragrance(parfum), Aloe Barbadensis, Tocopheryl Acetate Vitamin E

Package Label - Principal Display Panel

80ct NDC: 76665-012 -80

INGREDIENTS AND APPEARANCE

PRO-SANITIZE 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76665-012
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 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.1 mL  in 100 mL
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)	0.5 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	97.395 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.3 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76665-012-80	789 mL in 1 CANISTER; Type 0: Not a Combination Product	08/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/17/2020

Labeler - Clean Beauty Concepts (117491649)

Establishment
Name	Address	ID/FEI	Business Operations
Clean Beauty Concepts		117491649	manufacture(76665-012)