Label: HAND SANITIZER DR. BUTLER- ethyl alcohol gel
- NDC Code(s): 70942-157-08
- Packager: Beyond Health P.A.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 9, 2023
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- ACTIVE INGREDIENT
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- INDICATIONS & USAGE
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WARNINGS
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.
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- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HAND SANITIZER DR. BUTLER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70942-157 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 g in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:70942-157-08 237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/26/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/26/2020 Labeler - Beyond Health P.A. (026781064) Registrant - Derma Care Research Labs, LLC (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs, LLC 116817470 manufacture(70942-157)