SPL v1
SPL
SPL Set ID 38a7e4af-997d-549e-e063-6394a90a0bd6
Route
TOPICAL
Published
Effective Date 2025-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (5 g)
Inactive Ingredients
Niacinamide .alpha.-tocopherol Acetate Aloe Vera Leaf Ascorbyl Palmitate Canola Oil Carbomer Homopolymer, Unspecified Type Cetostearyl Alcohol Lemon Oil, Cold Pressed Edetate Disodium Ethylhexylglycerin Glycerin Glyceryl Monostearate Olive Oil Orange Oil, Cold Pressed Propylene Glycol Trolamine Vitamin A Palmitate Water Zea Mays (corn) Oil Pyridoxine Hcl Peg-100 Monostearate Stearic Acid Cholecalciferol Lavender Oil Phenoxyethanol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-28

Description

Dimethicone 5%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Dimethicone 5%

Uses

Uses

  • temporaily protects and helps relieve chafed, chapped or cracked skin
  • helps protect from the drying effects of whine and cold weather
  • helps treat and prevent diaper rash
  • protects minor skin irritation associated with diaper rash and helps seal out wetness
Section 51945-4

Warnings

Warnings

For external use only

Directions

Directions

As a skin protectant apply as needed

As a diaper cream

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

Dimethicone 5%

Inactive Ingredients

Water, Glyceryl Monostearate, Stearic Acid, PEG-100 Monostearate, Cetostearyl Alcohol, Glycerin, Propylene Glycol, Niacinamide, Pehenoxyethanol, Aloe Vera Leaf, Zea Mays Oil, Fragrance, Carbomer, Trolamine, Edetate Disodium, Orange Oil Cold Pressed, Canola Oil, Citrus Medica Limonum (Lemon) Peel Oil, Lavender Oil, Olive Oil, .Alpha.-Tocopherol Acetate, Ascorbyl Palmitate, Pyridoxine HCl, Vitamin A Palmitate, Cholecalciferol, Ethylhexylglycerin

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. In case of accidental ingestion contact a physician or Poison Control Center right away.


Structured Label Content

Uses

Uses

  • temporaily protects and helps relieve chafed, chapped or cracked skin
  • helps protect from the drying effects of whine and cold weather
  • helps treat and prevent diaper rash
  • protects minor skin irritation associated with diaper rash and helps seal out wetness
Section 51945-4 (51945-4)

Purpose

Skin Protectant

Warnings

Warnings

For external use only

Directions

Directions

As a skin protectant apply as needed

As a diaper cream

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

Dimethicone 5%

Inactive Ingredients

Water, Glyceryl Monostearate, Stearic Acid, PEG-100 Monostearate, Cetostearyl Alcohol, Glycerin, Propylene Glycol, Niacinamide, Pehenoxyethanol, Aloe Vera Leaf, Zea Mays Oil, Fragrance, Carbomer, Trolamine, Edetate Disodium, Orange Oil Cold Pressed, Canola Oil, Citrus Medica Limonum (Lemon) Peel Oil, Lavender Oil, Olive Oil, .Alpha.-Tocopherol Acetate, Ascorbyl Palmitate, Pyridoxine HCl, Vitamin A Palmitate, Cholecalciferol, Ethylhexylglycerin

When Using This Product (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)

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)

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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