FRIDA MOM HOSPITAL BAG ESSENTIALS COMPLETE- witch hazel kit

frida mom Hospital Bag Essentials Complete by

Drug Labeling and Warnings

frida mom Hospital Bag Essentials Complete 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

Perineal Cooling Pad Liners

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

• Remove one Pad Liner from pouch and place on top of maxi pad.
• Close lid after use to retain moisture.
• Replace Pad Liner with each maxi pad change.

Other information

• Store at room temperature
• Close lid after every use to retain moisture.
• Discard after every use.
• Not flushable.

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, menthyl lactate, sodium citrate

SPL UNCLASSIFIED SECTION

Perineal Healing Foam

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 - Kit Carton

frida mom

Hospital Bag Essentials
Complete Kit

The motherload of postpartum must-haves, from first
contractions to first post-baby toilet trip

We've got you covered

from
this...

...to this.

Push

Delivery and Nursing Gown
1 gown

Cleanse

Upside Down Peri Bottle
1 peri bottle

Cover

Disposable Postpartum Underwear
4 pairs

Cool + Absorb

Instant Ice Maxi Pads
4 pads

Soothe + Heal

Perineal Cooling Pad Liners
24 witch hazel liners

Perineal Healing Foam
witch hazel net 5 fl. oz.

Postpartum

INGREDIENTS AND APPEARANCE

FRIDA MOM HOSPITAL BAG ESSENTIALS COMPLETE 
witch hazel kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72705-250

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72705-250-01	1 in 1 CARTON	05/01/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 POUCH	24
Part 2	1 BOTTLE, PUMP	141.75 g

Part 1 of 2

FRIDA MOM PERINEAL COOLING PAD LINERS 
witch hazel cloth

Product Information
Item Code (Source)	NDC: 72705-100
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

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)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
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: 72705-100-01	24 in 1 POUCH; 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

Part 2 of 2

FRIDA MOM PERINEAL HEALING 
witch hazel aerosol, foam

Product Information
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: 72705-150-01	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

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.		600410514	MANUFACTURE(72705-250)

Establishment
Name	Address	ID/FEI	Business Operations
Fischer Pharmaceuticals Ltd.		600009856	MANUFACTURE(72705-250)