ALCOHOL ANTISEPTIC HAND SANITIZER NON-STERILE SOLUTION- alcohol gel 
Pegasus Biotechnology LLC.

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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Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution

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

Label

Package Labeling:100 ml

Label2

Package Labeling:250 ml

Label3

Package Labeling:500 ml

Label.4

Package Labeling: 1000

Label5

ALCOHOL ANTISEPTIC HAND SANITIZER NON-STERILE SOLUTION 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80095-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80095-000-0550 mL in 1 BOTTLE; Type 0: Not a Combination Product10/12/2020
2NDC:80095-000-10100 mL in 1 BOTTLE; Type 0: Not a Combination Product10/12/2020
3NDC:80095-000-25250 mL in 1 BOTTLE; Type 0: Not a Combination Product10/12/2020
4NDC:80095-000-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/12/2020
5NDC:80095-000-001000 mL in 1 BOTTLE; Type 0: Not a Combination Product10/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/12/2020
Labeler - Pegasus Biotechnology LLC. (121238045)

Revised: 9/2020
Document Id: ae41e260-623f-f4ea-e053-2995a90a6e6b
Set id: ae41da2e-8d69-b5be-e053-2a95a90a8e8c
Version: 1
Effective Time: 20200901
 
Pegasus Biotechnology LLC.