Label: CLEACE 75% ETHYL ALCOHOL DISINFECTANT- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 74621-025-01 - Packager: AOGRAND INTERNATIONAL TRADE CORPORATION
- 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 May 6, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only.
Flammable. ■ keep away from fire or flame, heat, spark, electrical.Ask a doctor before use for deep or puncture wounds, animal bites or serious burns.
When using this product ■ do not get into eyes. ■ do not apply over large areas of the body. ■ do not use longer than 1 week unless directed by a doctor.
Stop use and ask a doctor if condition persists or gets worse.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Caution - Fumes can be acutely irritating to skin, eyes and the respiratory system. Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes. Avoid inhaling this product.
- KEEP OUT OF REACH OF CHILDREN
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Directions
■ clean affected area.
■ apply small amount of this product on the area 1 to 3 times daily.
■ may be covered with a sterile bandage.
■ if bandaged, let dry first.Other information
■ Store at room temperature and avoid direct sunlight.
■ will produce serious gastric disturbances if taken internally.
■ For surface contact that may cause discoloration, test first in areas that are not obvious. - Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
CLEACE 75% ETHYL ALCOHOL DISINFECTANT
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74621-025 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74621-025-01 175 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/06/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/06/2020 Labeler - AOGRAND INTERNATIONAL TRADE CORPORATION (421353092) Establishment Name Address ID/FEI Business Operations AOGRAND INTERNATIONAL TRADE CORPORATION 421353092 manufacture(74621-025)
