Label: CLEACE- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 74621-002-01, 74621-002-02, 74621-002-03, 74621-002-04, view more74621-002-05, 74621-002-06, 74621-002-07, 74621-002-08, 74621-002-09, 74621-002-10, 74621-002-11 - Packager: Nanjing Aogrand Int'l 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 April 7, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only.
Flammable. Keep away from fire or flame.
Do not apply around eyes. Do not use in ears & mouth.
When using this product, avoid contact with eyes. In case of contact flush eyes with water.
Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- 1oz CLEACE
- 2oz CLEACE
- 3.4oz CLEACE
- 8oz CLEACE
- 10oz CLEACE
- 16.9oz CLEACE
- 33.8oz CLEACE
- 39.9oz CLEACE
- 50.7 oz CLEACE
- 169.1oz CLEACE
- 676.3oz CLEACE
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INGREDIENTS AND APPEARANCE
CLEACE
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74621-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 7.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74621-002-01 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/07/2020 2 NDC:74621-002-02 60 mL in 1 PACKAGE; Type 0: Not a Combination Product 04/07/2020 3 NDC:74621-002-03 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/07/2020 4 NDC:74621-002-04 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/07/2020 5 NDC:74621-002-05 296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/07/2020 6 NDC:74621-002-06 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/07/2020 7 NDC:74621-002-07 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/07/2020 8 NDC:74621-002-08 1180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/07/2020 9 NDC:74621-002-09 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/07/2020 10 NDC:74621-002-10 5000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/07/2020 11 NDC:74621-002-11 20000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/07/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/07/2020 Labeler - Nanjing Aogrand Int'l Corp (421353092) Establishment Name Address ID/FEI Business Operations Nanjing Aogrand Int'l Corp 421353092 manufacture(74621-002)