Zinc Oxide With Menthol & White Petrolatum

Zinc Oxide With Menthol & White Petrolatum
SPL v2
SPL
SPL Set ID f993fc0a-bd80-4345-a948-65ac03f910e2
Route
TOPICAL
Published
Effective Date 2025-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.44 g) Zinc Oxide (20.625 g) White Petrolatum (66.625 g)
Inactive Ingredients
Ferric Oxide Red Glycerin Phenol Lanolin Mineral Oil Sodium Bicarbonate Thymol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

Description

Menthol 0.44% Zinc Oxide 20.625% White Petrolatum USP 66.625%

Purpose

Analgesic External Analgesic Astringent/Protectant


Medication Information

Purpose

Analgesic

External Analgesic

Astringent/Protectant

Description

Menthol 0.44% Zinc Oxide 20.625% White Petrolatum USP 66.625%

Uses

■ gives temporary relief of local itching and discomfort in the perianal area

■ temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues

■ temporarily protects irritated areas 

■ temporarily relieves burning

■ provides temporary relief from skin irritations

■ temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

■ temporarily protects inflamed perianal skin

■ temporarily relieves the symptoms of perianal skin irritation

■ may provide a cooling sensation

Warnings

For external use only

Allergy Alert: certain persons 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.

Directions

■ Adults: 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 a soft cloth before application of this product. Apply to affected area up to 6 times daily.



■ Children under 12 years of age: consult a doctor

Questions?

Gopaldas Visram and Company Limited.

Address - A/327, TTC Industrial Area,

MIDC Mahape, Navi Mumbai,

Maharashtra 400710, India

Active Ingredient

Menthol 0.44%

Zinc Oxide 20.625%

White Petrolatum USP 66.625%

Other Information

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

Inactive Ingredients

Calamine, Glycerine, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol

When Using This Product

■ 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

■ condition worsens or does not improve in 7 days

■ bleeding occurs, consult a doctor promptly

Keep Out of Reach of Children

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

Zinc Oxide, Menthol and White Petrolatum


Structured Label Content

Uses

■ gives temporary relief of local itching and discomfort in the perianal area

■ temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues

■ temporarily protects irritated areas 

■ temporarily relieves burning

■ provides temporary relief from skin irritations

■ temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

■ temporarily protects inflamed perianal skin

■ temporarily relieves the symptoms of perianal skin irritation

■ may provide a cooling sensation

Purpose

Analgesic

External Analgesic

Astringent/Protectant

Warnings

For external use only

Allergy Alert: certain persons 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.

Directions

■ Adults: 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 a soft cloth before application of this product. Apply to affected area up to 6 times daily.



■ Children under 12 years of age: consult a doctor

Questions?

Gopaldas Visram and Company Limited.

Address - A/327, TTC Industrial Area,

MIDC Mahape, Navi Mumbai,

Maharashtra 400710, India

Active Ingredient

Menthol 0.44%

Zinc Oxide 20.625%

White Petrolatum USP 66.625%

Other Information

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

Inactive Ingredients

Calamine, Glycerine, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol

When Using This Product (When using this product)

■ 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 (Stop use and ask a doctor if)

■ condition worsens or does not improve in 7 days

■ bleeding occurs, consult a doctor promptly

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

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

Zinc Oxide, Menthol and White Petrolatum


Advanced Ingredient Data


Raw Label Data

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