DERMASIL DRYSKIN- dimethicone lotion

DERMASIL DRYSKIN by

Drug Labeling and Warnings

DERMASIL DRYSKIN by is a Otc medication manufactured, distributed, or labeled by Fantasia Beauty LLC, Guangdong Kingkey Fine Chemical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Dimethicone 1%

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.

• 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.

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 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 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 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 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 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 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 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)

INGREDIENTS AND APPEARANCE

DERMASIL DRYSKIN 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76184-0101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.01 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCOL STEARATE (UNII: 0324G66D0E)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-40 STEARATE (UNII: ECU18C66Q7)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETYL OLEATE (UNII: 78K2L26L8N)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
SUNFLOWER OIL (UNII: 3W1JG795YI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)
GERANIUM MACULATUM ROOT OIL (UNII: H2E371EDYX)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
BORAGE OIL (UNII: F8XAG1755S)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ALMOND OIL (UNII: 66YXD4DKO9)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
SANDALWOOD OIL (UNII: X7X01WMQ5F)
ROSA DAMASCENA FLOWER (UNII: JWB78P295A)
VANILLA (UNII: Q74T35078H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76184-0101-1	214 mL in 1 TUBE; Type 0: Not a Combination Product	08/30/2017
2	NDC: 76184-0101-2	236 mL in 1 TUBE; Type 0: Not a Combination Product	08/30/2017
3	NDC: 76184-0101-3	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/30/2017
4	NDC: 76184-0101-4	274 mL in 1 TUBE; Type 0: Not a Combination Product	08/30/2017
5	NDC: 76184-0101-5	296 mL in 1 TUBE; Type 0: Not a Combination Product	08/30/2017
6	NDC: 76184-0101-6	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/30/2017
7	NDC: 76184-0101-7	429 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/30/2017
8	NDC: 76184-0101-8	535 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/30/2017

Labeler - Fantasia Beauty LLC (037273190)

Establishment
Name	Address	ID/FEI	Business Operations
Guangdong Kingkey Fine Chemical Co., Ltd.		545349263	MANUFACTURE(76184-0101)