ALCOHOL ANTISEPTIC HAND SANITIZER NON-STERILE SOLUTION- alcohol gel

Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution by

Drug Labeling and Warnings

Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution by is a Otc medication manufactured, distributed, or labeled by Pegasus Biotechnology LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient[s]

Alcohol 80% v/v

Purpose

Antiseptic

Use[s]

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 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 chilren.

If swallowed, get medical help or contact a Poison Control Center 

Directions

Place enough product on hands to cover all surfaces. Rub hands together continuously 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

Aloe Vera, Vitamin E, Carbomer, TEA, Deionized Water, Fragrance, fd&c blue no.1

Package Labeling:50 ml

Package Labeling:100 ml

Package Labeling:250 ml

Package Labeling:500 ml

Package Labeling: 1000

INGREDIENTS AND APPEARANCE

ALCOHOL ANTISEPTIC HAND SANITIZER NON-STERILE SOLUTION 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80095-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TEA LEAF (UNII: GH42T47V24)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80095-000-05	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/12/2020
2	NDC: 80095-000-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/12/2020
3	NDC: 80095-000-25	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/12/2020
4	NDC: 80095-000-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/12/2020
5	NDC: 80095-000-00	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/12/2020

Labeler - Pegasus Biotechnology LLC. (121238045)