Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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ANTIBACTERIAL HAND SANITIZER- alcohol gel 
Fred's, Inc

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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Drug Facts

Active Ingredient

Ethyl alcohol 70%

purpose

Antiseptic

Use

  • to decrease bacteria on the skin that could cause disease
  • recommended for repeated use

Warnings

For external use only: hands

Flammable

Keep away from heat and flame

When using this product

  • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • avoid contact with broken skin
  • do not inhale or ingest

Stop use and ask a doctor if

  • irritation or redness develops
  • condition persists for more than 72 hours

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away

Directions

  • wet hands thoroghly with product and allow to dry without wiping
  • for children under 6, use only under adult supervision
  • not recommended for infants

Other information

  • do not store above 105⁰ F
  • may discolor some fabrics
  • harmful to wood finishes and plastics

Inactive ingredients

water, glyceryl caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4

Claims

Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little as 15 seconds

This product is not manufactured or distributed by GOJO industries, Inc. distributor of Purell Refreshing Gel Advanced Hand Sanitizer

Principal display panel

fred's Pharmacy

ADVANCED

Hand Sanitizer

Fresh Feeling Gel

Kills more than 99.99% of germs

Moisturizing formula with Vitamin E

Compare to Purell Advanced Hand Sanitizer

2 FL OZ (59 mL)

image description

ANTIBACTERIAL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55315-370
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
SULISOBENZONE (UNII: 1W6L629B4K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55315-370-1659 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/2015
2NDC: 55315-370-34236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/02/2015
Labeler - Fred's, Inc (005866116)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon088520668manufacture(55315-370)

Revised: 12/2018
 
Fred's, Inc


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