SPL v2
SPL
SPL Set ID e2a5270e-7c16-47bc-bd19-5652049b4dfd
Route
TOPICAL
Published
Effective Date 2020-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (14.7 g)
Inactive Ingredients
Water Mineral Oil Petrolatum White Wax Sorbitan Sesquioleate Glycerin Microcrystalline Wax Dimethicone Phenoxyethanol Ethylhexylglycerin Magnesium Sulfate, Unspecified Form Aloe Vera Leaf .alpha.-tocopherol Potassium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-04-01 Until 2026-09-13

Description

Drug Facts

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Drug Facts

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
Section 42229-5

Drug Facts

Warnings

For external use only

Directions
  • change wet and soiled diapers promptly
  • cleanse the diaper area
  • allow to dry
  • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Active Ingredient

Zinc Oxide (13%)

Other Information
  • store at 20° to 25°C (68° to 77°F)
  • protect from freezing
  • may stain clothing
Inactive Ingredients

Water, Mineral Oil (Paraffinium Liquidum), Petrolatum, Beeswax, Sorbitan Sesquioleate, Glycerin, Microcrystalline Wax, Dimethicone, Phenoxyethanol, Ethylhexylglycerin, Magnesium Sulfate, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Potassium Hydroxide.

When Using This Product
  • do not get into eyes.
Stop Use and Ask A Doctor 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 a Poison Control Center right away.

Principal Display Panel – Box Label

CVS

Health ®

Compare to the active

ingredient in Desitin ®Daily

Defense Diaper Rash Cream*

Cream

Diaper

Rash

Cream

ZINC OXIDE 13%

Skin protectant

Daily use for

diaper rash

Fast acting

Paraben Free

Fragrance free

NET WT 4 OZ (113 g)

Principal Display Panel – Tube Label

CVS

Health ®

Cream

Diaper

Rash

Cream

ZINC OXIDE 13%

Skin protectant

Daily use for

diaper rash

Fast acting

Paraben Free

Fragrance free

NET WT 4 OZ (113 g)


Structured Label Content

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
Section 42229-5 (42229-5)

Drug Facts

Purpose

Skin Protectant

Warnings

For external use only

Directions
  • change wet and soiled diapers promptly
  • cleanse the diaper area
  • allow to dry
  • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Active Ingredient (Active ingredient)

Zinc Oxide (13%)

Other Information (Other information)
  • store at 20° to 25°C (68° to 77°F)
  • protect from freezing
  • may stain clothing
Inactive Ingredients (Inactive ingredients)

Water, Mineral Oil (Paraffinium Liquidum), Petrolatum, Beeswax, Sorbitan Sesquioleate, Glycerin, Microcrystalline Wax, Dimethicone, Phenoxyethanol, Ethylhexylglycerin, Magnesium Sulfate, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Potassium Hydroxide.

When Using This Product (When using this product)
  • do not get into eyes.
Stop Use and Ask A Doctor If (Stop use and ask a doctor 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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel – Box Label

CVS

Health ®

Compare to the active

ingredient in Desitin ®Daily

Defense Diaper Rash Cream*

Cream

Diaper

Rash

Cream

ZINC OXIDE 13%

Skin protectant

Daily use for

diaper rash

Fast acting

Paraben Free

Fragrance free

NET WT 4 OZ (113 g)

Principal Display Panel – Tube Label

CVS

Health ®

Cream

Diaper

Rash

Cream

ZINC OXIDE 13%

Skin protectant

Daily use for

diaper rash

Fast acting

Paraben Free

Fragrance free

NET WT 4 OZ (113 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)