Label: DR. SAM PREMIUM HAND SANITIZER (500ML)- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78012-101-01 - Packager: G.E.O MARKETING CORP
- 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 June 2, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingedient
- Purpose
- Uses
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Warnings
For external use only
Do not use if you are allergic to any of the ingredients
When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. avoid contact with broken, irritated, or itching skin. Do not puncture or incinerate.
Stop use and ask a doctor if irritation or redness develops and condition persists for more than 72 hours.
If pregnant or breast-feeding, ask a health professional before use
- Keep out of reach of children
- Directions
- Inactive ingredients
- Dr. Sam Premium Hand Sanitizer (500mL)
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INGREDIENTS AND APPEARANCE
DR. SAM PREMIUM HAND SANITIZER (500ML)
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78012-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 g in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) LEVOMENTHOL (UNII: BZ1R15MTK7) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) ALOE (UNII: V5VD430YW9) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78012-101-01 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/25/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/25/2020 Labeler - G.E.O MARKETING CORP (080740733) Establishment Name Address ID/FEI Business Operations Korea Medicare Co.,Ltd. 695832135 manufacture(78012-101)