Active Ingredient
Dimethicone 1%
Dermasil Dryskin Lotion
FDA Label NDC 76184-0101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fantasia Beauty Llc for the product Dermasil Dryskin (NDC 76184-0101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - stop use, otc - keep out of reach of children, directions, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin protectant
Uses
- Temporarily protects and helps relieve chapped or cracked skin.
- Helps protect from the drying effects of wind and cold weather.
Warnings
- For external use only.
- Do not get into eyes.
Otc - Stop Use
- 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.
Otc - 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.
Directions
- Apply to Hands and Body every day.
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.
Principal Display Panel - Dermasil Dryskin 7.25 Tube Label
Dermasil®
LABS
Pharmaceutical Research
Controls Even Sever Dry Skin
Skin Lipid & EFA Treatment
Hypo-Allergenic
Dermasil®
Dry Skin Treatment
ORIGINAL LOTION
7.25 FL. OZ. (214 ml)
Principal Display Panel (Dermasil Dryskin 7.25 Tube Label)
Principal Display Panel - Dermasil Original 8 Tube Label
Dermasil®
LABS
Pharmaceutical Research
Controls Even Severe Dry Skin
Skin Lipid & EFA Treatment
Hypo-Allergenic
Dermasil®
Dry Skin Treatment
ORIGINAL LOTION
8 FL OZ (236 ml)
Principal Display Panel (Dermasil Original 8 Tube Label)
Principal Display Panel - Dermasil Original 8 Bottle Label
Dermasil®
LABS
Pharmaceutical Research
Controls Even Severe Dry Skin
Skin Lipid & EFA Treatment
Hypo-Allergenic
Dermasil®
Dry Skin Treatment
ORIGINAL LOTION
8 FL. OZ. (1/2 PINT, 237 ml)
Principal Display Panel (Dermasil Original 8 Bottle Label)
Principal Display Panel - Dermasil Dry Skin 9.25 Tube Label
VALUE
SIZE
Dermasil®
LABS
Pharmaceutical Research
Controls Even Severe Dry Skin
Skin Lipid & EFA Treatment
Hypo-Allergenic
Dermasil®
Dry Skin Treatment
ORIGINAL LOTION
9.25 FL. OZ. (274 ml)
Principal Display Panel (Dermasil Dry Skin 9.25 Tube Label)
Principal Display Panel - Dermasil Dryskin 10 Tube Label
Dermasil®
LABS
Pharmaceutical Research
Controls Even Severe Dry Skin
Skin Lipid & EFA Treatment
Hypo-Allergenic
Dermasil®
Dry Skin Treatment
ORIGINAL LOTION
10 FL. OZ. (296 ml)
Principal Display Panel (Dermasil Dryskin 10 Tube Label)
Principal Display Panel - Dermasil Dryskin 10 Bottle Label
Dermasil®
LABS
Pharmaceutical Research
Controls Even Severe Dry Skin
Skin Lipid & EFA Treatment
Hypo-Allergenic
Dermasil®
Dry Skin Treatment
ORIGINAL LOTION
10 FL. OZ. (3/5 PINT, 296 ml)
Principal Display Panel (Dermasil Dryskin 10 Bottle Label)
Principal Display Panel - Dermasil Dryskin 14.5 Bottle Label
Dermasil®
LABS
Pharmaceutical Research
Controls Even Severe Dry Skin
Skin Lipid & EFA Treatment
Hypo-Allergenic
Dermasil®
Dry Skin Treatment
ORIGINAL LOTION
14.5 FL. OZ. (0.9 PINT, 429 ml)
Principal Display Panel (Dermasil Dryskin 14.5 Bottle Label)
Principal Display Panel - Dermasil Dryskin 18.1 Bottle Label
25 %
MORE
Dermasil®
LABS
Pharmaceutical Research
Controls Even Severe Dry Skin
Skin Lipid & EFA Treatment
Hypo-Allergenic
Dermasil®
Dry Skin Treatment
ORIGINAL LOTION
18.1 FL. OZ. (1.1 PINT, 535 ml)
Principal Display Panel (Dermasil Dryskin 18.1 Bottle Label)
* Please review the disclaimer below.
