HAND SANITIZER- alcohol gel 
Actalys

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.

----------

500ml NDC: 79032-206-15

Retail Label

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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

  • 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 children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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 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

Glycerin, Water, Carbomer, Trolamine, Arnica mexicana (Heterotheca inuloides, extract)

Carton of 20 500ml bottles NDC: 79032-246-15

20 count carton label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79032-206
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 4.5 mL  in 500 mL
TROLAMINE (UNII: 9O3K93S3TK) 1 mL  in 500 mL
WATER (UNII: 059QF0KO0R) 141.85 mL  in 500 mL
HETEROTHECA INULOIDES FLOWER (UNII: W9NZ9OZF68) 0.1 mL  in 500 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.75 mL  in 500 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79032-206-1520 in 1 BOX07/30/2020
1NDC:79032-206-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/30/2020
Labeler - Actalys (260814505)
Registrant - Actalys (260814505)
Establishment
NameAddressID/FEIBusiness Operations
Actalys260814505api manufacture(79032-206)

Revised: 7/2020
Document Id: abab2e6e-583b-5362-e053-2995a90a95c3
Set id: ab971974-97b7-eeb1-e053-2a95a90aafef
Version: 2
Effective Time: 20200730
 
Actalys