CALPAK- alcohol gel
CALIFORNIA PAK INTERNATIONAL, INC

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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Active Ingredient

Ethyl Alcohol 70% v/v.

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 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 a doctor if irritation occurs.

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.
Do not use other than directed.

Other information

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

Inactive ingredients

Aqua/Water/Eau, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Fragrance/Parfum, Glycerin, Isopropyl Myristate, Triethanolamine.

Package Label - Principal Display Panel

image description

CALPAK
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80543-001
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80543-001-01	53 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/31/2020
2	NDC:80543-001-02	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/31/2020

Labeler - CALIFORNIA PAK INTERNATIONAL, INC (615304953)