SPL v3
SPL
SPL Set ID a68d6cda-2268-440a-9ca6-677c4e3ea0e7
Route
TOPICAL
Published
Effective Date 2024-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (1 g)
Inactive Ingredients
Polybutene (1400 Mw) Bis-diglyceryl Polyacyladipate-2 Sesame Oil Shea Butter Apricot Kernel Oil Ceresin Garcinia Indica Seed Butter Avocado Oil Silica Dimethyl Silylate .alpha.-tocopherol Acetate Benzyl Alcohol Limonene, (+)- Pouteria Sapota Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-01

Description

Dimethicone 1%

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Dimethicone 1%

Uses
  • Helps prevent and temporarily protects and helps relieve chapped or cracked lips
  • Helps prevent and protect from the drying effects of wind and cold weather
Section 50565-1

Warnings

For external use only

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 in a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply as needed

Product Label

Active Ingredient

Dimethicone 1%

Inactive Ingredients

Polybutene, Bis-Diglyceryl Polyacyladipate-2, Sesamum Indicum (Sesame) Seed Oil, Butyrospermum Parkii (Shea) Butter, Prunus Armeniaca (Apricot) Kernel Oil, Ozokerite, Garcinia Indica Seed Butter, Fragrance, Persea Gratissima (Avocado) Oil, Silica Dimethyl Silylate, Oleic / Linoleic / Linolenic Polyglycerides, Pouteria Sapota Seed Oil, Tocopheryl Acetate, Benzyl Alcohol, Limonene.


Structured Label Content

Uses
  • Helps prevent and temporarily protects and helps relieve chapped or cracked lips
  • Helps prevent and protect from the drying effects of wind and cold weather
Section 50565-1 (50565-1)

Purpose

Skin protectant

Warnings

For external use only

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 in a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply as needed

Product Label (Product label)

Active Ingredient

Dimethicone 1%

Inactive Ingredients

Polybutene, Bis-Diglyceryl Polyacyladipate-2, Sesamum Indicum (Sesame) Seed Oil, Butyrospermum Parkii (Shea) Butter, Prunus Armeniaca (Apricot) Kernel Oil, Ozokerite, Garcinia Indica Seed Butter, Fragrance, Persea Gratissima (Avocado) Oil, Silica Dimethyl Silylate, Oleic / Linoleic / Linolenic Polyglycerides, Pouteria Sapota Seed Oil, Tocopheryl Acetate, Benzyl Alcohol, Limonene.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)