HAND SANITIZER GEL- alcohol gel 
BERIOSKA SL

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(s)

Alcohol 70% w/w. 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.

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, purified water USP, acrylates/C10-30 alkyl acrylate crosspolymer, PEG-40 hidrogenated castor oil, triethanolamine, CI 42090

Package Label - Principal Display Panel

Sanitizer 300ml Label300 mL NDC: 78283-100-14

HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78283-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL222.72299 mL  in 300 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 73.29594 mL  in 300 mL
GLYCERIN (UNII: PDC6A3C0OX) 2.57722 mL  in 300 mL
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.23195 mL  in 300 mL
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) 1.03089 mL  in 300 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.14072 mL  in 300 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00028 mL  in 300 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78283-100-14300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - BERIOSKA SL (462392556)
Registrant - BERIOSKA SL (462392556)

Revised: 9/2020
Document Id: af91ff79-4e5c-1beb-e053-2995a90a7b77
Set id: a62b5739-24ae-4e1e-e053-2a95a90a4d97
Version: 2
Effective Time: 20200918
 
BERIOSKA SL