PROSKI SOOTHE- menthol, zinc oxide cream

PROSKI SOOTHE by

Drug Labeling and Warnings

PROSKI SOOTHE by is a Otc medication manufactured, distributed, or labeled by PHARMAMED USA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 0.44%

Zinc Oxide 20.625%

INDICATION

External Analgesic

Skin Protectant

Anorectal analgesic and astringent

USE

• Helps relieve the itching and discomfort associated with anorectal disorders
• For the temporary relief of irritation and burning
• May provide a cooling sensation

A moisture barrier that prevents and helps heal skin irritations from:

Urine Diarrhea Perspiration Fistula drainage Feeding tube site leakage Wound drainage (peri-wound skin) Minor burns Cuts Scrapes Itching

WARNINGS

For external use only

Do not use

• On deep or puncture wounds
• If pregnant or breast feeding, ask a health professional before use.

When using this product

Avoid contact with eyes

Do not exceed the recommended daily dosage unless directed by a doctor

Certain people can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult 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

Condition worsens, or symptoms do not improve within 7 days, consult a doctor bleeding occurs redness, irritation, swelling, or pain develops or increases

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DIRECTIONS

Adults: When practical, cleanse the affected area skin with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply to the affected area up to 6 times daily or after each bowel movement.

Children under 12 years of age: Consult a doctor

OTHER INFORMATION

Store at room temperature 15º-30º C (59º-86º F)

Tamper evident. Do not use if packet is torn or cut. Do not use if seal is damaged.

INACTIVE INGREDIENTS

Ferric Oxide Red, Glycerin, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol, White Petrolatum

QUESTIONS OR COMMENTS?

(754)-200-8994 (Mon-Fri 8 AM to 4 PM EST)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC: 84289-234-01

ANORECTAL (HEMORRHOIDAL OINTMENT) WITH MENTHOL 0.44% AND ZINC OXIDE 20.625%

ENHANCED FORMULA

CALMS AND COOLS

FAST-ACTING RELIEF

ENRICHED WITH CALAMINE AND LANOLIN FOR COMFORT

Net Wt 4 oz. (113 g)

GO/DRUGS/571

INGREDIENTS AND APPEARANCE

PROSKI SOOTHE 
menthol, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84289-234
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	21 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.44 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
THYMOL (UNII: 3J50XA376E)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
MINERAL OIL (UNII: T5L8T28FGP)
LANOLIN (UNII: 7EV65EAW6H)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84289-234-01	113 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/01/2025

Labeler - PHARMAMED USA INC (065607328)