HAND SANITIZER DR. BUTLER- ethyl alcohol gel 
Beyond Health P.A.

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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Hand Sanitizer

Ethyl Alcohol 62%


Antiseptic

To decrease bacteria on the skin that could cause disease. Recommended for repeated use.

For external use only. Flammable-keep away from fire or flame. When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water, avoid contact with broken skin, and do not inhale or ingest. Stop use and ask a doctor if rash or irritation develops and lasts for more than 72 hours.

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

Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

Water, Isopropyl Alcohol, Tocopheryl Acetate, Glycerin, Propylene Glycol, Isopropyl Myristate, Carbomer, Aminomethyl Propanol.

Label

HAND SANITIZER  DR. BUTLER
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70942-157
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70942-157-08237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/26/2020
Labeler - Beyond Health P.A. (026781064)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(70942-157)

Revised: 1/2023
Document Id: f1d91cd2-6d14-3e7b-e053-2a95a90ab05c
Set id: a1c48934-6e9d-dba6-e053-2995a90ab05d
Version: 2
Effective Time: 20230109
 
Beyond Health P.A.