Label: FRIDA MOM HEALING FOAM- salicylic acid aerosol, foam
- NDC Code(s): 58443-0550-4
- Packager: Prime Enterprises, Inc.
- Category: HUMAN OTC DRUG LABEL
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 21, 2022
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
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Warnings
For external use only
When using this product
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not exceed the recommended daily dosage unless directed by a doctor.
- Do not put this product into the rectum by using fingers or any mechanical device or applicator.
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Directions
Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Add foam on top of pad or pad liner. Children under 12 years of age: consult a doctor. Apply to the affected area up to 6 times daily or after each bowel movement.
- Other information
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Inactive ingredients
Hamamelis Virginiana (Witch Hazel) Extract, Water, Glycerin, Alcohol, Sodium Lauroamphoacetate, Phenoxyethanol, Benzoic Acid, Tocopherol, Sodium Benzoate, Dehydroacetic Acid, Caprylic/Capric Triglyceride, Sodium Citrate, Mentha Piperita (Peppermint) Oil, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid
- Frida mom Perineal Healing Foam
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INGREDIENTS AND APPEARANCE
FRIDA MOM HEALING FOAM
salicylic acid aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0550 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 510 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SODIUM CITRATE (UNII: 1Q73Q2JULR) PEPPERMINT OIL (UNII: AV092KU4JH) CHAMOMILE (UNII: FGL3685T2X) SODIUM BENZOATE (UNII: OJ245FE5EU) HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) DEHYDROACETIC ACID (UNII: 2KAG279R6R) SODIUM LAUROAMPHOACETATE (UNII: SLK428451L) PHENOXYETHANOL (UNII: HIE492ZZ3T) BENZOIC ACID (UNII: 8SKN0B0MIM) TOCOPHEROL (UNII: R0ZB2556P8) Product Characteristics Color yellow (Very Light Yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0550-4 139 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 04/21/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 04/21/2022 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 manufacture(58443-0550) , pack(58443-0550) , analysis(58443-0550) , label(58443-0550)