Active Ingredients
Menthol 0.44%
Zinc Oxide 20.625%
Calmoseptine
FDA Label NDC 54868-5287
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Calmoseptine (NDC 54868-5287). 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 active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic / Anti-itch
Skin protectant / Anorectal astringent
Uses
Uses: A moisture barrier that prevents and helps heal skin irritation from:
urine, diarrhea, perspiration, fistula damage, feeding tube site leakage,
wound drainage (peri-wound skin), minor burns, cuts, scrapes, itching
Warnings
Warnings: For external use only. Not for deep or puncture wounds. Avoid contact with eyes.
In case of accidental ingestion contact a physician or poison control center immediately. If condition
worsens or does not improve within 7 days, consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Directions
Directions: Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply
a thin layer of Calmoseptine Ointment to reddened or irritated skin 2-4 times daily, or after
each incontinent episode or diaper change to promote comfort and long lasting protection.
Inactive Ingredients
Inactive ingredients: Calamine, chlorothymol, glycerin, lanolin, phenol,
sodium bicarbonate, and thymol in a suitable ointment base
Principal Display Panel
Calmoseptine Ointment
Menthol 0.44%
Zinc Oxide 20.6%
71 gram tube
NDC 54868-5287-0
Image Of Tube (5287)
Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
* Please review the disclaimer below.
