Active Ingredients
Menthol 0.44%
Zinc Oxide 20.6%
Calprotect Ointment
FDA Label NDC 69618-067
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reliable 1 Laboratories Llc for the product Calprotect (NDC 69618-067). 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, other information, inactive ingredients, 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 astrigent
Uses
A moisture barrier that prevents and helps heal skin irritations from
- urine
- diarrhea
- perspiration
- fistula drainage
- feeding tube site leakage
- wound drainage (per-wound skin)
- minor burns
- cuts
- scrapes
- itching
Warnings
For external use only
- Not for deep or puncture wounds
- Avoid contact with eyes
- Incase of accidental ingestion, contact a physician or posion contril immediately
- If condition worsens or does not improve in 7 days, consult a doctor
- Do not put this product into the rectum by using fingers or any machanical device or applicator
- Children under 12 years of age: consult a doctor
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Directions
Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Calprotect 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.
Other Information
Store between 15-30°C (59-86°F)
Inactive Ingredients
calamine, chlorothymol, glycerin, lanolin, phenol, sodium bicarbonate, and thymol in a suitable ointment base
Questions Or Comments?
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Package Label.Principal Display Panel
Protects, Soothes & Promotes Healing
NDC 69618-067-82
Compare to active ingredients in Calmoseptine*
CalProtect Ointment
External use only
Made in the USA
*Reliable-1 Labs is not affiliated with the owner of the registered trademark Calmoseptine
* Please review the disclaimer below.
