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Calmoseptine by Calmoseptine Inc.

Medically reviewed on August 8, 2017.

Dosage form: ointment
Ingredients: LANOLIN 15.7g in 100g, MENTHOL 0.44g in 100g, PETROLATUM 24g in 100g, ZINC OXIDE 20.6g in 100g
Labeler: Calmoseptine Inc.
NDC Code: 0799-0001

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.

Calmoseptine Ointment 

Active Ingredients 

Lanolin 15.7%  

Menthol 0.44%

Petrolatum 24%

Zinc Oxide 20.6%

Purpose

Active Ingredients                                        Purpose
Lanolin 15.7%...........................Anorectal Protectant
Menthol 0.44%...........................Anorectal Analgesic
Petrolatum 24%........................Anorectal Protectant
Zinc Oxide 20.6%......Anorectal Protectant, Astringent 

Uses
  • Temporarily protects irritated areas.
  • For the temporary relief of:
  •   local itching and discomfort in the perianal area
  •   pain or burning
  •   skin irritations

Warnings

For external use only

When using this product

* Certain persons can develop allergic reactions to ingredients in this product.
* Do not put this product into the rectum by using fingers or any mechanical device or applicator.
* Do not exceed the recommended daily dosage unless directed by a doctor.
* Avoid contact with eyes.

Stop use and ask doctor if
  • condition worsens or does not improve within 7 days
  • bleeding occurs
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

Keep out of reach of children.

In case of accidental ingestion contact a physician or Poison Control Center immediately.

Directions

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
Gently dry by patting or blotting with toilet tissue or a soft cloth or air dry 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.

Inactive Ingredients:

calamine, chlorothymol, glycerin, phenol,

sodium bicarbonate, and thymol in a suitable ointment base

Calmoseptine Ointment

CALMOSEPTINE 
anorectal ointment ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0799-0001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANOLIN (LANOLIN) LANOLIN15.7 g  in 100 g
MENTHOL (MENTHOL) MENTHOL0.44 g  in 100 g
PETROLATUM (PETROLATUM) PETROLATUM24 g  in 100 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE20.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED 
CHLOROTHYMOL 
GLYCERIN 
PHENOL 
SODIUM BICARBONATE 
THYMOL 
Packaging
#Item CodePackage Description
1NDC:0799-0001-0271 g in 1 TUBE
2NDC:0799-0001-0371 g in 1 JAR
3NDC:0799-0001-04113 g in 1 TUBE
4NDC:0799-0001-053.5 g in 1 PACKET
5NDC:0799-0001-0620 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34608/01/1950
Labeler - Calmoseptine Inc. (783409394)
Establishment
NameAddressID/FEIOperations
Calmo Manufacturing Inc.015850149manufacture(0799-0001), pack(0799-0001), label(0799-0001)

 
Calmoseptine Inc.

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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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