Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID d19f482c-bec7-45aa-b22f-fe91a3dc717d
Route
TOPICAL
Published
Effective Date 2025-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (10 mg)
Inactive Ingredients
Water Hydrogenated Polybutene (1300 Mw) Glycerin Shea Butter Panthenol Butylene Glycol Propanediol Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Trihydroxystearin Zinc Gluconate Madecassoside Manganese Gluconate Silicon Dioxide Aluminum Hydroxide Zea Mays (corn) Starch Centella Asiatica Whole Polymnia Sonchifolia Root Juice Alpha-glucan Oligosaccharide Mannose Capryloyl Glycine Trisodium Ethylenediamine Disuccinate Lactobacillus Maltodextrin Pentylene Glycol Magnesium Sulfate, Unspecified Form Citric Acid Monohydrate Acetylated Glycol Stearate Polyglyceryl-4 Isostearate Tocopherol Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Phenoxyethanol Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-15
Description

Dimethicone 1%

Purpose

Skin protectant

Medication Information

Purpose

Skin protectant

Description

Dimethicone 1%

Uses
  • temporarily protects and helps relieve chafed, chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
Section 51945-4

Warnings

For external use only

Directions
  • apply as needed

For diaper rash:

  • change wet and soiled diapers promptly, cleanse the diaper area, and 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
Do Not Use
  • on deep or puncture wounds
  • animal bites
  • serious burns
Active Ingredient

Dimethicone 1%

Other Information

● store at room temperature

Inactive Ingredients

wwater, hydrogenated polyisobutene, dimethicone, glycerin, butyrospermum parkii (shea) butter, panthenol, zea mays (corn) starch, propanediol, butylene glycol, cetyl PEG/PPG-10/1 dimethicone, trihydroxystearin, centella asiatica leaf extract, polymnia sonchifolia root juice, zinc gluconate, madecassoside, manganese gluconate, alpha-glucan oligosaccharide, silica, aluminum hydroxide, magnesium sulfate, mannose, capryloyl glycine, vitreoscilla ferment, citric acid, trisodium ethylenediamine disuccinate, lactobacillus, acetylated glycol stearate, maltodextrin, pentylene glycol, polyglyceryl-4 isostearate, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, titanium dioxide

Questions Or Comments?

1-888-LRP-LABO  1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

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.

Structured Label Content

Uses
  • temporarily protects and helps relieve chafed, chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
Section 51945-4 (51945-4)

Purpose

Skin protectant

Warnings

For external use only

Directions
  • apply as needed

For diaper rash:

  • change wet and soiled diapers promptly, cleanse the diaper area, and 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
Do Not Use (Do not use)
  • on deep or puncture wounds
  • animal bites
  • serious burns
Active Ingredient (Active ingredient)

Dimethicone 1%

Other Information (Other information)

● store at room temperature

Inactive Ingredients (Inactive ingredients)

wwater, hydrogenated polyisobutene, dimethicone, glycerin, butyrospermum parkii (shea) butter, panthenol, zea mays (corn) starch, propanediol, butylene glycol, cetyl PEG/PPG-10/1 dimethicone, trihydroxystearin, centella asiatica leaf extract, polymnia sonchifolia root juice, zinc gluconate, madecassoside, manganese gluconate, alpha-glucan oligosaccharide, silica, aluminum hydroxide, magnesium sulfate, mannose, capryloyl glycine, vitreoscilla ferment, citric acid, trisodium ethylenediamine disuccinate, lactobacillus, acetylated glycol stearate, maltodextrin, pentylene glycol, polyglyceryl-4 isostearate, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-LRP-LABO  1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:37.830559 · Updated: 2026-03-14T23:09:29.869893