Label: ETHYL ALCOHOL- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 52305-001-30 - Packager: Freshorize LTD
- 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 March 17, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Inactive Ingredients
- Directions
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Warnings:
Flammable. Keep away from fire or flames. For external use only.
Keep out of reach of children.
Avoid contact with eyes.
In case of contact, rinse eyes throroughly with water.
Stop use and ask a doctor if skin irritation develops.
If ingested, get medical help or contact a
Poison Control Centre immediatly. - Active Ingredient
- Other Information
- Purpose
- Uses
- Front Label area
- Package Label
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INGREDIENTS AND APPEARANCE
ETHYL ALCOHOL
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52305-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.001 mL in 100 mL CARBOMER 934 (UNII: Z135WT9208) 0.28 mL in 100 mL .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.001 mL in 100 mL WATER (UNII: 059QF0KO0R) 37.307 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.3 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.001 mL in 100 mL Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52305-001-30 300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/17/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/17/2021 Labeler - Freshorize LTD (424168503) Registrant - Freshorize LLC (018206924)