Safe Hands® Hand Sanitizer Gel Alcohol Free

Safe Hands Hand Sanitizer Alcohol Free by

Drug Labeling and Warnings

Safe Hands Hand Sanitizer Alcohol Free 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 ALCOHOL FREE- benzalkonium chloride 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 Alcohol Free

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

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

Warnings

  • For external use only.

  • 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

  • Pump a small amount of gel into palm of hand
  • Rub hands together briskly until dry
  • Rub thoroughly over all surfaces of both hands

Inactive ingredients

Aqua, Glycereth-26, Triethylene Glycol, Cocoamidopropyl PG-Dimonium Chloride Phosphate, Aroma, Hydroxyethylcellulose, Triethanolamine, DMDM Hydantoin and Iodopropynyl Butylcarbamate.

PRINCIPAL DISPLAY PANEL - 284 ml Bottle Label

HAND SANITIZER GEL

Alcohol free

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.
284mle

PRINCIPAL DISPLAY PANEL - 284 ml Bottle Label
SAFE HANDS HAND SANITIZER ALCOHOL FREE 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71489-003
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
GLYCERETH-26 (UNII: NNE56F2N14)  
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)  
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR)  
TROLAMINE (UNII: 9O3K93S3TK)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71489-003-01284 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/05/201701/03/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E07/05/201701/03/2019
Labeler - Celeste Industries Corporation (047795034)

Revised: 12/2019
Document Id: e7076ba8-1912-4bba-9918-079aabea9177
Set id: 40db1142-3ee1-4ea1-9d4c-4e02860c421c
Version: 2
Effective Time: 20191223
 
Celeste Industries Corporation