FDA.reportPublic FDA data

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

Manufacturer
PHARMAMED USA INC
Effective date
2026-05-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
weekly-update
Hydrated at
2026-06-03 18:02:32

Label at a glance#

ProductPROSKI SOOTHE
Active ingredientZINC OXIDE, MENTHOL
Label structure10 sections

Dosage and administration

• 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

Storage and handling

• 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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.44%

Zinc Oxide 20.625%

INDICATION

OTC - PURPOSE SECTION

External Analgesic

Skin Protectant

Anorectal analgesic and astringent

USE

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

•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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

• 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

INACTIVE INGREDIENT SECTION

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

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

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

Recent Major Changes (§ 201.57(a)(5)) Rev. 05-05-2026

RECENT MAJOR CHANGES SECTION

• Boxed Warning
• Indications and Usage
• Dosage and Administration
• Contraindications
• Warnings and Precautions

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

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

Inner Label ImageInner Label Image

Outer Label ImageOuter Label Image

Pinted InsertPinted Insert

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84289-23484289-234-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOL339NCG44TVIACT
GLYCERINPDC6A3C0OXIACT
THYMOL3J50XA376EIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
SODIUM BICARBONATE8MDF5V39QOIACT
MINERAL OILT5L8T28FGPIACT
LANOLIN7EV65EAW6HIACT
ZINC OXIDESOI2LOH54ZACTIB
MENTHOLL7T10EIP3AACTIB
FERRIC OXIDE RED1K09F3G675IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5259fda1-5497-a76c-e063-6394a90a432a2c7b23a1-76cb-095e-e063-6294a90ac6f22026-05-21WarningsExact identifier
spl set id: 2c7b23a1-76cb-095e-e063-6294a90ac6f2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.