Drug Facts
Active ingredients
Menthol 0.44%
Zinc oxide 20.6%
Moisture Barrier Ointment
FDA Label NDC 0363-6254
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Moisture Barrier (NDC 0363-6254). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purposes, uses, warnings, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
External analgesic / Anti-itch
Skin protectant / Anorectal astringent
Uses
A coating that temporarily protects inflamed and irritated skin and helps provide temporary relief of:
- burning
- skin irritations
- anorectal discomforts
- painful bowel movements
- itching
Warnings
For external use only
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 within 7 days
- bleeding occurs
- the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
If swallowed, get medical help or contact a Poison Control Center right away
Directions
Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply externally 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 temperature: not to exceed 30° C (86° F).
Inactive Ingredients
calamine, glycerin, lanolin, petrolatum, phenol, sodium bicarbonate, thymol, vitamin E (tocopherol acetate)
Questions?
1-800-925-4733
Other
DISTRIBUTED BY: WALGREEN CO.,
DEERFIELD, IL 60015 100% SATISFACTION GUARANTEED
walgreens.com ©2024 Walgreen Co.
†Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands.
††This product is not manufactured or distributed by Calmoseptine Inc., the owner of the registered trademark Calmoseptine Ointment®.
NDC 0363-6254-07
Package Label.Principal Display Panel
Walgreens
Walgreens Pharmacist Recommended†
Compare to the active ingredients in Calmoseptine Ointment®††
Moisture Barrier Ointment
MENTHOL 0.44% / EXTERNAL ANALGESIC
ZINC OXIDE 20.6% / ANORECTAL ASTRINGENT
- May provide a cooling sensation
- Temporary relief of irritation or burning
NET WT 4 OZ (113 g)
* Please review the disclaimer below.
