a68d6cda-2268-440a-9ca6-677c4e3ea0e7

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

Purpose

Skin protectant

Description

Dimethicone 1%


Medication Information

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.

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
Purpose

Skin protectant

Directions

• apply as needed

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.

Description

Dimethicone 1%

Section 50565-1

Product Label

Active Ingredient

Dimethicone 1%


Structured Label Content

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.

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
Purpose

Skin protectant

Directions

• apply as needed

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.

Section 50565-1 (50565-1)

Product Label (Product label)

Active Ingredient

Dimethicone 1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)