Medpura

Medpura
SPL v4
SPL
SPL Set ID 5359d92e-641e-4076-9d91-18daee58a30e
Route
TOPICAL
Published
Effective Date 2023-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.44 g) Zinc Oxide (20.6 g)
Inactive Ingredients
White Petrolatum Ferric Oxide Red Chlorothymol Glycerin Lanolin Phenol Sodium Bicarbonate Thymol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-13

Description

Menthol 0.44% Zinc Oxide 20.6%

Purpose

Active Ingredients                                        Purpose Menthol 0.44%...........................External analgesic/anti-itch Zinc Oxide 20.6%......Skin protectant/anorectal astringent 


Medication Information

Purpose

Active Ingredients                                        Purpose

Menthol 0.44%...........................External analgesic/anti-itch

Zinc Oxide 20.6%......Skin protectant/anorectal astringent 

Description

Menthol 0.44% Zinc Oxide 20.6%

Uses
  • A moisture barrier that prevents and heals skin irritations from
  • urine
  • diarrhea
  • prespiration
  • fistula drainage
  • feeding tube site leakage
  • wound drainage (peri-wound skin)
  • minor burns
  • cuts
  • scrapes
  • itching
Section 51945-4

Warnings

For external use only

Directions

Cleanse skin gently with mid skin cleanser. Pat dry or allow to air dry. apply a thin layer of Hydroseptine 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.

Active Ingredients 

Menthol 0.44%

Zinc Oxide 20.6%

Inactive Ingredients:

Other information store at room temperature 15-30 C (59-86 F)

Inactive ingredients calamine, chlorothymol, glycerin, lanoline,phenol, sodium bicarbonate, and thymol,white petrolatum

Questions or Comments? Call toll-free 1-877-255-6999

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

www.akronpharma.com

This product is not manufactured or distributed by Calmoseptine Inc., owner of the registered trademark Calmoseptine.

When Using This Product
  • not for deep or punctured wounds
  • avoid contact with eyes
Stop Use and Ask Doctor If
  • In case of accidental ingestion contact a physician or Poison Control Center right away
  • if condition worsens or does not improve within 7 days, consult a doctor
Keep Out of Reach of Children.


Structured Label Content

Uses
  • A moisture barrier that prevents and heals skin irritations from
  • urine
  • diarrhea
  • prespiration
  • fistula drainage
  • feeding tube site leakage
  • wound drainage (peri-wound skin)
  • minor burns
  • cuts
  • scrapes
  • itching
Section 51945-4 (51945-4)

Purpose

Active Ingredients                                        Purpose

Menthol 0.44%...........................External analgesic/anti-itch

Zinc Oxide 20.6%......Skin protectant/anorectal astringent 

Warnings

For external use only

Directions

Cleanse skin gently with mid skin cleanser. Pat dry or allow to air dry. apply a thin layer of Hydroseptine 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.

Active Ingredients 

Menthol 0.44%

Zinc Oxide 20.6%

Inactive Ingredients:

Other information store at room temperature 15-30 C (59-86 F)

Inactive ingredients calamine, chlorothymol, glycerin, lanoline,phenol, sodium bicarbonate, and thymol,white petrolatum

Questions or Comments? Call toll-free 1-877-255-6999

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

www.akronpharma.com

This product is not manufactured or distributed by Calmoseptine Inc., owner of the registered trademark Calmoseptine.

When Using This Product (When using this product)
  • not for deep or punctured wounds
  • avoid contact with eyes
Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • In case of accidental ingestion contact a physician or Poison Control Center right away
  • if condition worsens or does not improve within 7 days, consult a doctor
Keep Out of Reach of Children. (Keep out of reach of children.)


Advanced Ingredient Data


Raw Label Data

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