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THERASEPTIN by Cal Pharma

Medically reviewed on February 19, 2018

Dosage form: ointment
Ingredients: ZINC OXIDE 20.6g in 100mL, MENTHOL 0.5g in 100mL
Labeler: Cal Pharma
NDC Code: 55628-9109

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.

METHYL SALICYLATE (28%)

MENTHOL (10%)

CAPSAICIN (0.25%)

TOPICAL ANALGESIC

Uses: A moisture barrier that prevents & helps heal skin irritations from: urine, diarrhea, perspiration, stula, drainage, feeding tube site leakage, wound drainage (peri-wound skin), minor burns, cuts, scrapes, itching

WARNINGS: FOR EXTERNAL USE ONLY

Avoid contact with eyes. In case of contact, flush thoroughly with warm water

Not for use on deep or puncture wounds.

Stop use and ask a doctor if condition worsens or does not improve within 7 days.

Keep out of reach of children: In case of accidental ingestion contact a physician or Poison Control Center right away.

DIRECTIONS

- APPLY ON CLEAN SKIN AND GENTLY RUB OVER AREA WITH PAIN. DO NOT USE MORE THAN 4 TIMES A DAY. WASH HANDS AFTER LOTION IS APPLIED AND RUBBED ONTO SKIN.

Inactive Ingredients: Calamine, Chlorothymol, Glycerin, Lanolin, Methylparaben, Petrolatum, Phenol, Propylparaben, Sodium Bicarbonate, Thymol

THERASEPTIN 
zinc oxide menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55628-9109
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE20.6 g  in 100 mL
MENTHOL (MENTHOL) MENTHOL0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CHLOROTHYMOL 
GLYCERIN 
LANOLIN 
METHYLPARABEN 
PETROLATUM 
PHENOL 
PROPYLPARABEN 
SODIUM BICARBONATE 
THYMOL 
Packaging
#Item CodePackage Description
1NDC:55628-9109-4120 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/29/2012
Labeler - Cal Pharma (078721283)

 
Cal Pharma

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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