Safe Hands® Foaming Hand Sanitizer Alcohol Free

Safe Hands Foaming Hand Sanitizer Alcohol Free by

Drug Labeling and Warnings

Safe Hands Foaming 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 FOAMING HAND SANITIZER ALCOHOL FREE- benzalkonium chloride liquid 
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® Foaming Hand Sanitizer 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 foam into palm of hand
  • Rub thoroughly over all surfaces of both hands
  • Rub hands together briskly until dry

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

FOAMING HAND SANITIZER
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.
8 fl oz 236ml e

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label
SAFE HANDS FOAMING HAND SANITIZER ALCOHOL FREE 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71489-002
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: 71489-002-01236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/26/201702/13/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E06/26/201702/13/2019
Labeler - Celeste Industries Corporation (047795034)

Revised: 12/2019
Document Id: ee7b6e46-5070-4b9d-aa21-6e8a084f113a
Set id: 4de93686-6a79-4f4b-9cd0-e345a73b256f
Version: 2
Effective Time: 20191223
 
Celeste Industries Corporation