HAND SANITIZER GEL- alcohol gel

Hand Sanitizer Gel by

Drug Labeling and Warnings

Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Califormulations LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

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

WHEN USING

When using this product

• Keep out of eyes. In case of contact with eyes, rinse eyes thoroughly with water
• Avoid contact with broken skin
• Do not inhale or ingest

STOP USE

Stop use and ask a doctor if

• irritation and redness develop
• condition persist for more than 72 hours

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

• Wet hands thoroughly wit product to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product.
• Not recommended for infants.

Other information

• Avoid freezing and excessive heat above 40C (104F)
• May discolor certain fabrics or surfaces

Inactive ingredients

Water, Acrylates Copolymer, Aloe Barbadensis Leaf Juice, Triethanolamine, Frangrance (Parfum)

Package Label - Principal Display Panel

3785 mL NDC: 74391-003-01

237 mL NDC: 74391-003-08

INGREDIENTS AND APPEARANCE

HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74391-003
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
TRIETHYLAMINE (UNII: VOU728O6AY)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74391-003-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/03/2020
2	NDC: 74391-003-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/03/2020

Labeler - Califormulations LLC (945269491)

Establishment
Name	Address	ID/FEI	Business Operations
Califormulations LLC		945269491	manufacture(74391-003)