FRIDA MOM LABOR AND DELIVERY PLUS POSTPARTUM RECOVERY- witch hazel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Witch Hazel (UNII: 101I4J0U34) (Witch Hazel - UNII:101I4J0U34)
Available from:
Fridababy, LLC
Prescription type:
OTC DRUG
Therapeutic indications:
Astringent - Helps relieve pain and swelling from hemorrhoids and childbirth. - Temporary relief from: Irritation Burning Discomfort - Irritation - Burning - Discomfort Astringent - Helps relieve pain and swelling from hemorrhoids and childbirth. - Temporary relief from: Irritation Burning Discomfort - Irritation - Burning - Discomfort
Authorization status:
OTC monograph final
Authorization number:
72705-100-01, 72705-150-01, 72705-251-02

FRIDA MOM LABOR AND DELIVERY PLUS POSTPARTUM RECOVERY- witch hazel

Fridababy, LLC

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 Labor and Delivery + Postpartum Recovery Kit

Perineal Cooling Pad Liners

Drug Facts

Active ingredient

Witch Hazel 50%

Purpos e

Astringent

Us es

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

Perineal Healing Foam

Drug Facts

Active ingredient

Witch Hazel 50%

Purpos e

Astringent

Us es

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

Labor and Delivery +

Postpartum Recovery Kit

The motherload of labor + recovery must-haves,

from first contractions to first post-baby toilet trip

You've hit the motherload

Pack + Push

Bathroom

Essentials Bag

Delivery and

Nursing Gown + Socks

1 gown + 1 pair of socks

Cleanse

Upside

Down Peri Bottle

1 peri bottle

Cover

Disposable

Postpartum Underwear

4 pairs

Cool + Absorb

Instant

Ice Maxi Pads

4 pads

Soothe + Relieve Pain

Perineal

Cooling Pad Liners

24 witch hazel liners

Perineal

Healing Foam

witch hazel net 5 fl. oz.

Postpartum

FRIDA MOM LABOR AND DELIVERY PLUS POSTPARTUM RECOVERY

witch hazel kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7270 5-251

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7270 5-251-0 2

1 in 1 CARTON

0 5/0 1/20 19

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 POUCH

Pa rt 2

1 BOTTLE, PUMP

141.75 g

Part 1 of 2

FRIDA MOM PERINEAL COOLING PAD LINERS

witch hazel cloth

Product Information

Ite m Code (Source )

NDC:7270 5-10 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Witch Ha zel (UNII: 10 1I4J0 U34) (Witch Hazel - UNII:10 1I4J0 U34)

Witch Hazel

0 .5 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

SO DIUM LAURO AMPHO ACETATE (UNII: SLK428 451L)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

BENZO IC ACID (UNII: 8 SKN0 B0 MIM)

DEHYDRO ACETIC ACID (UNII: 2KAG279 R6 R)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

MENTHYL LACTATE, ( -) - (UNII: 2BF9 E6 5L7I)

SO DIUM CITRATE, UNSPECIFIED FO RM (UNII: 1Q73Q2JULR)

Product Characteristics

Color

WHITE

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7270 5-10 0 -0 1

24 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt346

0 5/0 1/20 19

Part 2 of 2

FRIDA MOM PERINEAL HEALING

witch hazel aerosol, foam

Product Information

Ite m Code (Source )

NDC:7270 5-150

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Witch Ha zel (UNII: 10 1I4J0 U34) (Witch Hazel - UNII:10 1I4J0 U34)

Witch Hazel

0 .5 g in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

SO DIUM LAURO AMPHO ACETATE (UNII: SLK428 451L)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

BENZO IC ACID (UNII: 8 SKN0 B0 MIM)

DEHYDRO ACETIC ACID (UNII: 2KAG279 R6 R)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

SO DIUM CITRATE, UNSPECIFIED FO RM (UNII: 1Q73Q2JULR)

Product Characteristics

Color

WHITE

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:7270 5-150 -

141.75 g in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt346

0 5/0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Fridababy, LLC

OTC mo no graph final

pa rt346

0 5/0 1/20 19

Labeler -

Fridababy, LLC (783729598)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Fischer Pharmaceuticals Ltd.

6 0 0 410 514

MANUFACTURE(7270 5-251)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Fischer Pharmaceuticals Ltd.

6 0 0 0 0 9 8 56

MANUFACTURE(7270 5-251)

Revised: 4/2019

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