PRO-SANITIZE ADVANCED WITH ALOE VERA- hand sanitizer liquid

Pro-Sanitize Advanced with Aloe Vera by

Drug Labeling and Warnings

Pro-Sanitize Advanced with Aloe Vera 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 hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water. (27.465%)
5. Acrylates/C10 30 Alkyl acrylate crosspolymer(.20% v/v)
6. Aminomethyl propanol (.06% v/v)
7. Fragrance (Parfum) (.3% v/v)
8. Aloe vera lead extract (0.4%)

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Hand Sanitizer 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

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• 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, acrylates/C10 30 alkyl acrylate crosspolymer, aminomethyl propanol, hydrogen peroxide, fragrance(parfum), Aloe Barbadensis

Package Label - Principal Display Panel

473 mL NDC: 76665-004-16

60 mL NDC: 76665-004-02

236 mL NDC: 76665-004-08

INGREDIENTS AND APPEARANCE

PRO-SANITIZE ADVANCED WITH ALOE VERA 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76665-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)	0.2 mL  in 100 mL
EUCALYPTUS OIL (UNII: 2R04ONI662)	0.3 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)	27.465 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.06 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.4 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76665-004-16	473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/25/2020
2	NDC: 76665-004-02	60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/25/2020
3	NDC: 76665-004-08	236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/25/2020

Labeler - Clean Beauty Concepts (117491649)

Establishment
Name	Address	ID/FEI	Business Operations
Clean Beauty Concepts		117491649	manufacture(76665-004)