THE FEMME FIX HEMORRHOID TREATMENT- lidocaine, phenylephrine hydrochloride ointment

The Femme Fix Hemorrhoid Treatment by

Drug Labeling and Warnings

The Femme Fix Hemorrhoid Treatment by is a Otc medication manufactured, distributed, or labeled by POPPY COLLECTIVE LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Lidocaine 4%
Phenylephrine HCL 0.25%

Purpose

Local Anesthetic
Vasoconstrictor

Uses

–Helps relieve the pain, itching, and burning associated with hemorrhoids.
–Temporarily reduce the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders.
–Temporarily provides a coating for relief of anorectal discomforts.
–Temporarily protects irritated areas and inflamed perianal skin.

Warnings

For external use only.
Allergy Alert
Certain persons can develop allergic reactions to ingreadients in this product

Ask a doctor before use if you have:

–Heart disease; high blood pressure; thyroid disease; diabetes.
–Difficulty in urination due to enlargement of the prostate gland.

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug for high blood pressure or depression.

When using this product

–Avoid contact with eyes.
–Do not exceed 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

–Bleeding occurs.
–Condition worsens or does not improve within 7 days.
–Allergic reaction occurs to ingredients in this product.
–Symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

If pregnant or breast-feeding,

ask a doctor before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

–When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
–Adults and children 12 years and older: apply externally to the affected area up to 4 times daily.
–Children under 12 years of age: consult a doctor.

Other Information

–Store at 20-25°C (68-77°F). Excursions permitted to 10-30°C (59-86°F).

Inactive Ingredients

alcohol, aloe barbadensis leaf extract, beeswax, BHA, C12-15 alkyl benzoate, caprylic/capric triglyceride, caprylyl glycol, citric acid, cocos nucifera (coconut) oil, euphorbia cerifera (candelilla) wax, glycerin, glyceryl laurate, glyceryl undecylenate, hamamelis virginiana (witch hazel) water, helianthus annuus (sunflower) seed oil, lanolin, lanolin alcohol, lavandula angustifolia (lavender) flower oil, magnesium sulfate, petrolatum, tapioca starch, water (aqua).

Package Labeling:

INGREDIENTS AND APPEARANCE

THE FEMME FIX HEMORRHOID TREATMENT 
lidocaine, phenylephrine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82433-946
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	2.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCONUT OIL (UNII: Q9L0O73W7L)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL LAURATE (UNII: Y98611C087)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LANOLIN (UNII: 7EV65EAW6H)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
PETROLATUM (UNII: 4T6H12BN9U)
STARCH, TAPIOCA (UNII: 24SC3U704I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82433-946-00	1 in 1 BOX	05/01/2025
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	05/01/2025

Labeler - POPPY COLLECTIVE LLC (035330878)

Registrant - Pure Source, LLC (080354456)