Paulas Choice Hand Sanitizer by PAULA'S CHOICE Hand Sanitizer

Paulas Choice Hand Sanitizer by

Drug Labeling and Warnings

Paulas Choice Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by PAULA'S CHOICE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PAULAS CHOICE HAND SANITIZER- ethyl alcohol gel 
PAULA'S CHOICE

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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Hand Sanitizer

Inactive Ingredients: Water (Aqua), Glycerin, Carbomer, Aminomethyl Propanol, Propanediol, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Propylene Glycol.

Antiseptic

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.

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

Do not use:

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

Stop use and ask a doctor if rash occurs. This may be a sign of a serious condition.

Stop use and ask a doctor if rash occurs. This may be a sign of a serious condition.

When using this product keep out eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

Stop use and ask a doctor if rash occurs. This may be a sign of a serious condition.

• Storebetween15°- 30°C (59°-86° F)
• Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients: Water (Aqua), Glycerin, Carbomer, Aminomethyl Propanol, Propanediol, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Propylene Glycol.

PAULAS CHOICE HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76144-192
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	625 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER 940 (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
JOJOBA OIL (UNII: 724GKU717M)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-192-00	125 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/14/2020

Labeler - PAULA'S CHOICE (029583981)

Revised: 1/2022

Document Id: c54df529-c318-dacd-e053-2995a90a60e9

34390-5

Set id: ab9cfccd-43c9-61f9-e053-2995a90a7ec7

Version: 4

Effective Time: 20220106