PERINEAL COOLING PAD LINERS- frida mom perineal cooling pad liners swab

Perineal Cooling Pad Liners by

Drug Labeling and Warnings

Perineal Cooling Pad Liners by is a Otc medication manufactured, distributed, or labeled by Fridababy, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Witch Hazel 50% w/w. Purpose: Astringent

PURPOSE

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.

INDICATIONS & USAGE

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.

Not required.

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

alcohol, benzoic acid, caprylic/capric triglyceride, chamomilla recutita flower extract, citric acid,dehydroacetic acid, glycerin, limonene, mentha piperita oil, menthyl lactate, phenoxyethanol, polyglyceryl-4 caprate, potassium sorbate, sodium benzoate, sodium citrate, tocopherol, water

Package Label - Principal Display Panel.

24 Liners. NDC: 72705-0420-1.

INGREDIENTS AND APPEARANCE

PERINEAL COOLING PAD LINERS 
frida mom perineal cooling pad liners swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72705-420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	50 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)	8.824 g  in 100 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.016 g  in 100 g
DEHYDROACETIC ACID (UNII: 2KAG279R6R)	0.11 g  in 100 g
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.3 g  in 100 g
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)	0.08 g  in 100 g
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)	0.05 g  in 100 g
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.715 g  in 100 g
WATER (UNII: 059QF0KO0R)	29.967 g  in 100 g
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)	0.1 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	8.0035 g  in 100 g
POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885)	1.494 g  in 100 g
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.0002 g  in 100 g
PEPPERMINT OIL (UNII: AV092KU4JH)	0.04 g  in 100 g
BENZOIC ACID (UNII: 8SKN0B0MIM)	0.275 g  in 100 g
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)	0.0175 g  in 100 g
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)	0.02 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72705-420-01	100 g in 1 PACKAGE; Type 0: Not a Combination Product	01/15/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	01/15/2023

Labeler - Fridababy, LLC (783729598)