COOLING PERINEAL PAD LINERS- cooling perineal cloth

Cooling Perineal Pad Liners by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Witch Hazel 50%

PURPOSE

* Help relieve pain and swelling from hemorrhoids and childbirth

* Temporary relief from: irritation, burning, discomfort

INDICATIONS & USAGE

* Help relieve pain and swelling from hemorrhoids and childbirth

* Temporary relief from: irritation, burning, discomfort

WARNINGS

For external use only

WHEN USING

When using this product:

* Avoid contact with eyes. If contact occurs, rinse thorougly with water.

* Do not exceed the recommended daily dosage unless directed by doctor.

* Do not put this product into the rectum by using fingers or any mechanical device or applicator.

STOP USE

Stop use and ask and ask a dotor 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.

DOSAGE & ADMINISTRATION

* Remove one liner from the pack and reseal the lid.

* Place the liner on top of a maxi pad.

* Close lid after use to retain moisture.

* Replace Pad liner with each maxi pad change

INACTIVE INGREDIENT

Water, aloe barbadensis leaf extract,, citric acid, decyl glucoside, glycerin, potassium sorbate, sodium benzoate, phenoxyethanol

STORAGE AND HANDLING

* Store at room temperature

* Single use per wipe

* Close lid after every use to retain moisture

* Discard after every use

* Not flushable

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOLING PERINEAL PAD LINERS 
cooling perineal cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79747-010
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 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
CITRIC ACID (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79747-010-01	30 mL in 1 CASE; Type 0: Not a Combination Product	10/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	10/15/2024

Labeler - ELEEO BRANDS LLC (078476782)