SPL v1
SPL
SPL Set ID da09e418-e9b1-42d5-8685-18cd601cc8f6
Route
TOPICAL
Published
Effective Date 2023-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (0.01 g)
Inactive Ingredients
Water Glycerin Petrolatum Mineral Oil Stearic Acid Glycol Stearate Glyceryl Monostearate Peg-40 Monostearate Cetyl Alcohol Cetyl Oleate Sodium Hydroxide Phenoxyethanol Carbomer Homopolymer Type C Sunflower Oil Edetate Disodium Acetylated Lanolin Alcohols Methylisothiazolinone Iodopropynyl Butylcarbamate Magnesium Aluminum Silicate Lecithin, Soybean Borage Oil Cholesterol Ascorbyl Palmitate Almond Oil Ethylene Brassylate Sandalwood Oil Rosa Damascena Flower Vanilla Niacinamide Inositol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-07-17

Description

Dimethicone 1%

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Dimethicone 1%

Use

Temporarily protects and helps relieve chapped or cracked skin.

Helps protect from the drying effects of wind and cold weather.

Section 50565-1

Warnings

For external use only.

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.

Directions

Apply to Hands and Body every day.

Active Ingredient

Dimethicone 1%

Inactive Ingredients:

WATER (AQUA), GLYCERIN, PETROLATUM, MINERAL OIL (PARAFFINUM LIQUIDUM), STEARIC ACID, GLYCOL STEARATE, GLYCERYL STEARATE, PEG-40 STEARATE, CETYL ALCOHOL, CETYL ACETATE, SODIUM HYDROXIDE, PHENOXYETHANOL, CARBOMER, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, DISODIUM EDTA, ACETYLATED LANOLIN ALCOHOL, GERANIUM MACULATUM OIL, METHYLISOTHIAZOLINONE, IODOPROPYNYL BUTYLCARBAMATE, MAGNESIUM ALUMINUM SILICATE, LECITHIN , BORAGO OFFICINALIS SEED OIL, CHOLESTEROL, ASCORBYL PALMITATE, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, ETHYLENE BRASSYLATE, SANTALUM ALBUM (SANDALWOOD) OIL, ROSA DAMASCENA EXTRACT, VANILLA PLANIFOLIA FRUIT EXTRACT.

Package Label Principal Display Panel

Dermasil®

LABS

Pharmaceutical Research

Controls Even Sever Dry Skin

Skin Lipid & EFA Treatment

Hypo-Allergenic

Dermasil®

Advanced Treatment

CREAMY LOTION

8 FL OZ (236 ml)

NDC: 73928-101-01


Structured Label Content

Use

Temporarily protects and helps relieve chapped or cracked skin.

Helps protect from the drying effects of wind and cold weather.

Section 50565-1 (50565-1)

Purpose (PURPOSE)

Skin protectant

Warnings

For external use only.

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.

Directions (DIRECTIONS)

Apply to Hands and Body every day.

Active Ingredient (ACTIVE INGREDIENT)

Dimethicone 1%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER (AQUA), GLYCERIN, PETROLATUM, MINERAL OIL (PARAFFINUM LIQUIDUM), STEARIC ACID, GLYCOL STEARATE, GLYCERYL STEARATE, PEG-40 STEARATE, CETYL ALCOHOL, CETYL ACETATE, SODIUM HYDROXIDE, PHENOXYETHANOL, CARBOMER, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, DISODIUM EDTA, ACETYLATED LANOLIN ALCOHOL, GERANIUM MACULATUM OIL, METHYLISOTHIAZOLINONE, IODOPROPYNYL BUTYLCARBAMATE, MAGNESIUM ALUMINUM SILICATE, LECITHIN , BORAGO OFFICINALIS SEED OIL, CHOLESTEROL, ASCORBYL PALMITATE, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, ETHYLENE BRASSYLATE, SANTALUM ALBUM (SANDALWOOD) OIL, ROSA DAMASCENA EXTRACT, VANILLA PLANIFOLIA FRUIT EXTRACT.

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Dermasil®

LABS

Pharmaceutical Research

Controls Even Sever Dry Skin

Skin Lipid & EFA Treatment

Hypo-Allergenic

Dermasil®

Advanced Treatment

CREAMY LOTION

8 FL OZ (236 ml)

NDC: 73928-101-01


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)