FRIDA MOM PERINEAL HEALING- witch hazel aerosol, foam

frida mom Perineal Healing by

Drug Labeling and Warnings

frida mom Perineal Healing by is a Otc medication manufactured, distributed, or labeled by Fridababy, LLC, Fischer Pharmaceuticals Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Witch Hazel 50%

Purpose

Astringent

Uses

• Helps relieve pain and swelling from hemorrhoids and childbirth.
• Temporary relief from:
  • Irritation
  • Burning
  • Discomfort

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

• Cleanse the affected area using a peri bottle or mild soap and warm water.
• Add foam on top of each new pad or pad liner for healing relief.
• Children under 12 years of age: consult a doctor before use.

Other information

• Store at room temperature
• Single use per wipe

Inactive ingredients

water, glycerin, alcohol, sodium lauroamphoacetate, chamomilla recutita extract, caprylic/capric triglyceride, tocopherol, phenoxyethanol, benzoic acid, dehydroacetic acid, sodium benzoate, citric acid, mentha piperita oil, sodium citrate

PRINCIPAL DISPLAY PANEL - 5 fl. oz. Bottle Carton

frida mom

Perineal
Healing Foam

Cooling pain relief
from vag to tush

Foam...

Witch Hazel

Speeds healing
Reduces swelling
No harsh chemicals

Postpartum
Net 5 fl. oz.

INGREDIENTS AND APPEARANCE

FRIDA MOM PERINEAL HEALING 
witch hazel aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72705-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Witch Hazel (UNII: 101I4J0U34) (Witch Hazel - UNII:101I4J0U34)	Witch Hazel	0.5 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72705-150-02	1 in 1 CARTON	05/01/2019
1	NDC: 72705-150-01	141.75 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part346	05/01/2019

Labeler - Fridababy, LLC (783729598)

Establishment
Name	Address	ID/FEI	Business Operations
Fischer Pharmaceuticals Ltd.		600009856	MANUFACTURE(72705-150)