CALMOSEPTINE
-
zinc oxide and
menthol ointment
Calmoseptine Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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: 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.
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: Calamine, chlorothymol, glycerin, lanolin, phenol,
sodium bicarbonate, and thymol in a suitable ointment base
CALMOSEPTINE
zinc oxide and menthol ointment |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part347 | 08/01/1950 |
Labeler - Calmoseptine Inc. (783409394) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Calmo Manufacturing Inc | 015850149 | manufacture, pack |
Revised: 01/2012 Calmoseptine Inc.