FRIDA MOM HEALING FOAM- salicylic acid aerosol, foam 
Prime Enterprises, Inc.

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.

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Frida mom Perineal Healing Foam

Active ingredients

Witch Hazel 50%

Purpose

Astringent

Uses

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.

Stop use and ask a doctor if

  • Rectal bleeding occurs.
  • Condition worsens or does not improve within 7 days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

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

Principle Display Label

FRIDA MOM  HEALING FOAM
salicylic acid aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0550
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL510 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
Coloryellow (Very Light Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0550-4139 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/21/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/21/2022
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(58443-0550) , pack(58443-0550) , analysis(58443-0550) , label(58443-0550)

Revised: 4/2022
Document Id: dd2dc09a-3b66-0dd6-e053-2a95a90abcfb
Set id: dd2dbffe-d839-16bc-e053-2995a90a7777
Version: 1
Effective Time: 20220421
 
Prime Enterprises, Inc.