Label: RECENS FOAM- alcohol liquid
- NDC Code(s): 75990-968-07, 75990-968-12, 75990-968-17
- Packager: Certus Medical, Inc.
- 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 October 4, 2022
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- Drug Facts Box OTC-Active Ingredient Section
- Drug Facts Box OTC-Purpose Section
- Drug Facts Box OTC-Indications & Usage Section
- Drug Facts Box OTC-Warnings Section
- Drug Facts Box OTC-When Using Section
- Drug Facts Box OTC-Stop Use Section
- Drug Facts Box OTC-Keep Out of Reach of Children Section
- Drug Facts Box OTC-Dosage & Administration Section
- Drug Facts Box OTC-Inactive Ingredient Section
- Recens Foam 6968
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INGREDIENTS AND APPEARANCE
RECENS FOAM
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75990-968 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75990-968-07 700 mL in 1 BAG; Type 0: Not a Combination Product 10/04/2022 2 NDC:75990-968-12 1000 mL in 1 BAG; Type 0: Not a Combination Product 10/04/2022 3 NDC:75990-968-17 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/04/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 10/04/2022 Labeler - Certus Medical, Inc. (118806847) Registrant - ABC Compounding Co., Inc. (003284353) Establishment Name Address ID/FEI Business Operations ABC Compounding Co., Inc. 003284353 manufacture(75990-968)
Recens Foam 6968