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Calmoseptine by Calmoseptine Inc.

Medically reviewed by Drugs.com. Last updated on Jan 22, 2019.

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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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More about Calmoseptine (menthol / zinc oxide topical)

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