SAFE HAND CLEAN GEL- alcohol gel 
ACE PHARMACEUTICAL CO LTD

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

ethanol

Glycerin
Butylene Glycol
Sodium Hyaluronate
Carbomer
Triethanolamine
Fragrance
Camellia Sinensis Leaf Extract
Aloe Barbadensis Leaf Juice
Water

hand sanitizer to help reduce bacteria that potentially can cause disease

for use when soap and water are not available

KEEP OUT OF REACH OF THE CHILDREN

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

Supervise children in the use of this product.

Dispense appropriate amount on your palm and thoroughly spread on both hands and rub into the skin until dry

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

for external use only

label

SAFE HAND CLEAN GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74196-0003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74196-0003-1500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/07/2020
Labeler - ACE PHARMACEUTICAL CO LTD (689058677)
Registrant - ACE PHARMACEUTICAL CO LTD (689058677)
Establishment
NameAddressID/FEIBusiness Operations
ACE PHARMACEUTICAL CO LTD689058677manufacture(74196-0003)

Revised: 5/2020
Document Id: a50a908d-a6e1-93fb-e053-2995a90a5704
Set id: a50a9c34-383e-9f30-e053-2a95a90a3f64
Version: 1
Effective Time: 20200507
 
ACE PHARMACEUTICAL CO LTD