Barrier Protectant Cream

Barrier Protectant Cream
SPL v4
SPL
SPL Set ID 539d9aac-75cf-4efd-bb3e-b465563304ca
Route
TOPICAL
Published
Effective Date 2015-11-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 mg) Zinc Oxide (200 mg)
Inactive Ingredients
Aloe Vera Leaf Ferric Oxide Red Chamomile Cod Liver Oil Edetate Disodium Glycerin Lanolin Light Mineral Oil Honey Methylparaben Microcrystalline Wax Petrolatum Propylparaben Sodium Borate Sorbitan Monooleate Tocopherol Water

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-01-15

Description

Menthol 0.1% Zinc oxide 20%

Purpose

Anorectal analgesic Skin protectant


Medication Information

Purpose
  • Anorectal analgesic
  • Skin protectant
Description

Menthol 0.1% Zinc oxide 20%

Uses

A moisture barrier that provides temporary relief from skin irritations caused by   •urine   •diarrhea   •perspiration   •fistula drainage   •feeding tube site leakage   •wound drainage (peri-wound skin)   •minor burns   •cuts   •scrapes   •anorectal itching   •chafing

Dries the oozing and weeping of poison   •ivy   •oak   •sumac

Section 50565-1

Keep out of reach of children.

Warnings

For external use only.

  • Avoid contact with the eyes
  • Stop use and contact a physician if condition worsens, symptoms last more than 7 days, or clear up and occur again within a few days.
  • Keep out of reach of children
  • If swallowed, get medical help or contact Poison Control Center right away.

Do not use:

  • On deep or puncture wounds
  • Animal bites
  • Serious burns
Directions
  • Gently cleanse and remove any urine or fecal matter from the treatment area
  • Pat dry
  • Apply a generous amount of product to the affected area
  • Repeat after every incontinent episode or as needed
  • For peri-G tubes: •Cleanse as above  •Apply thin layer  •Secure with drain sponge or product as directed.
Other Information

Store between 59°-86°F (15°-30°C)

Active Ingredients
  • Menthol 0.1%
  • Zinc oxide 20%
Inactive Ingredients

Active aloe gel, Calamine, Chamomilla recutita (matricaria) flower extract, Cod liver oil, Disodium EDTA, Glycerin, Lanolin, Light mineral oil, Manuka honey, Methylparaben, Microcrystalline wax, Petrolatum, Propylparaben, Sodium borate, Sorbitan oleate, Tocopherol, Water

Barrier Protectant Cream Labeling

Tube Label (2 oz)

Tube Label (4 oz)

Packet Labels (Box of 150)


Structured Label Content

Uses

A moisture barrier that provides temporary relief from skin irritations caused by   •urine   •diarrhea   •perspiration   •fistula drainage   •feeding tube site leakage   •wound drainage (peri-wound skin)   •minor burns   •cuts   •scrapes   •anorectal itching   •chafing

Dries the oozing and weeping of poison   •ivy   •oak   •sumac

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose
  • Anorectal analgesic
  • Skin protectant
Warnings

For external use only.

  • Avoid contact with the eyes
  • Stop use and contact a physician if condition worsens, symptoms last more than 7 days, or clear up and occur again within a few days.
  • Keep out of reach of children
  • If swallowed, get medical help or contact Poison Control Center right away.

Do not use:

  • On deep or puncture wounds
  • Animal bites
  • Serious burns
Directions
  • Gently cleanse and remove any urine or fecal matter from the treatment area
  • Pat dry
  • Apply a generous amount of product to the affected area
  • Repeat after every incontinent episode or as needed
  • For peri-G tubes: •Cleanse as above  •Apply thin layer  •Secure with drain sponge or product as directed.
Other Information (Other information)

Store between 59°-86°F (15°-30°C)

Active Ingredients (Active ingredients)
  • Menthol 0.1%
  • Zinc oxide 20%
Inactive Ingredients

Active aloe gel, Calamine, Chamomilla recutita (matricaria) flower extract, Cod liver oil, Disodium EDTA, Glycerin, Lanolin, Light mineral oil, Manuka honey, Methylparaben, Microcrystalline wax, Petrolatum, Propylparaben, Sodium borate, Sorbitan oleate, Tocopherol, Water

Barrier Protectant Cream Labeling

Tube Label (2 oz)

Tube Label (4 oz)

Packet Labels (Box of 150)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)