Safe Hands® Hand Sanitizer Gel with Alcohol

Safe Hands Hand Sanitizer with Alcohol by

Drug Labeling and Warnings

Safe Hands Hand Sanitizer with Alcohol by is a Otc medication manufactured, distributed, or labeled by Celeste Industries Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SAFE HANDS HAND SANITIZER WITH ALCOHOL- alcohol gel 
Celeste Industries Corporation

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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Safe Hands® Hand Sanitizer Gel with Alcohol

Drug Facts

Active ingredient

Ethyl Alcohol 62.5%

Purpose

Antimicrobial

Uses

  • For hand sanitizing to decrease bacteria on the skin
  • Recommended for repeated use

Warnings

  • For external use only.
  • Flammable. Keep away from fire or flame.

  • When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

  • Stop use and ask a doctor if irritation or redness develops, or if 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

  • Place enough product in your palm to thoroughly cover your hands
  • Rub hands together briskly until dry
  • Children under 6 years of age should be supervised when using this product.

Other information

  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces

Inactive ingredients

Aqua, PEG-4 Diheptanoate, Acrylates/C10-30 Alkyl Acrylate crosspolymer, Fragrance, Aminomethyl Propanol

PRINCIPAL DISPLAY PANEL - 284 ml Bottle Label

HAND SANITIZER GEL
with Alcohol

Kills 99% of germs on contact

Safe
Hands®

Requires no water or
towels. Apply small
amount to hands
and rub until dry.

Caution: Use on hands only.
284ml e

PRINCIPAL DISPLAY PANEL - 284 ml Bottle Label
SAFE HANDS HAND SANITIZER WITH ALCOHOL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71489-001
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.625 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PEG-4 DIHEPTANOATE (UNII: 2DQ7O61VHJ)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71489-001-01284 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/15/201706/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E06/15/201701/03/2019
Labeler - Celeste Industries Corporation (047795034)

Revised: 12/2019
Document Id: c6103c58-bf5b-4937-a56e-4782d74a4897
Set id: cf789869-e831-4a4e-b1dd-20f962c2eb3c
Version: 3
Effective Time: 20191223
 
Celeste Industries Corporation