Calprotect Ointment

Calprotect Ointment
SPL v5
SPL
SPL Set ID 09fb2810-0cc1-b2e2-e063-6294a90a4576
Route
TOPICAL
Published
Effective Date 2021-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-01

Description

Menthol 0.44% Zinc Oxide 20.6%

Purpose

External analgesic / Anti-itch Skin protectant / Anorectal astrigent


Medication Information

Purpose

External analgesic / Anti-itch

Skin protectant / Anorectal astrigent

Description

Menthol 0.44% Zinc Oxide 20.6%

Uses

A moisture barrier that prevents and helps heal skin irritations from

  • urine
  • diarrhea
  • perspiration
  • fistula drainage
  • feeding tube site leakage
  • wound drainage (per-wound skin)
  • minor burns
  • cuts
  • scrapes
  • itching
Section 50565-1

Keep out of reach of children

Section 51945-4

Protects, Soothes & Promotes Healing

NDC 69618-067-82

Compare to active ingredients in Calmoseptine*

CalProtect Ointment

External use only

Made in the USA

*Reliable-1 Labs is not affiliated with the owner of the registered trademark Calmoseptine

Warnings

For external use only

  • Not for deep or puncture wounds
  • Avoid contact with eyes
  • Incase of accidental ingestion, contact a physician or posion contril immediately
  • If condition worsens or does not improve in 7 days, consult a doctor
  • Do not put this product into the rectum by using fingers or any machanical device or applicator
  • Children under 12 years of age: consult a doctor
Directions

Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Calprotect 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.

Other Information

Store between 15-30°C (59-86°F)

Active Ingredients

Menthol 0.44%

Zinc Oxide 20.6%

Inactive Ingredients

calamine, chlorothymol, glycerin, lanolin, phenol, sodium bicarbonate, and thymol in a suitable ointment base

Questions Or Comments?

1-516-341-0666 8:30 am-4:30 pm EST Mon-Fri


Structured Label Content

Uses

A moisture barrier that prevents and helps heal skin irritations from

  • urine
  • diarrhea
  • perspiration
  • fistula drainage
  • feeding tube site leakage
  • wound drainage (per-wound skin)
  • minor burns
  • cuts
  • scrapes
  • itching
Section 50565-1 (50565-1)

Keep out of reach of children

Section 51945-4 (51945-4)

Protects, Soothes & Promotes Healing

NDC 69618-067-82

Compare to active ingredients in Calmoseptine*

CalProtect Ointment

External use only

Made in the USA

*Reliable-1 Labs is not affiliated with the owner of the registered trademark Calmoseptine

Purpose

External analgesic / Anti-itch

Skin protectant / Anorectal astrigent

Warnings

For external use only

  • Not for deep or puncture wounds
  • Avoid contact with eyes
  • Incase of accidental ingestion, contact a physician or posion contril immediately
  • If condition worsens or does not improve in 7 days, consult a doctor
  • Do not put this product into the rectum by using fingers or any machanical device or applicator
  • Children under 12 years of age: consult a doctor
Directions

Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Calprotect 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.

Other Information (Other information)

Store between 15-30°C (59-86°F)

Active Ingredients (Active ingredients)

Menthol 0.44%

Zinc Oxide 20.6%

Inactive Ingredients (Inactive ingredients)

calamine, chlorothymol, glycerin, lanolin, phenol, sodium bicarbonate, and thymol in a suitable ointment base

Questions Or Comments? (Questions or comments?)

1-516-341-0666 8:30 am-4:30 pm EST Mon-Fri


Advanced Ingredient Data


Raw Label Data

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