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 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

DERMASIL DRYSKIN
dimethicone lotion

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76184-0101-2	236 mL in 1 TUBE; Type 0: Not a Combination Product	08/30/2017
2	NDC:76184-0101-3	429 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2023
3	NDC:76184-0101-4	535 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	08/30/2017

Labeler - Fantasia Beauty LLC (037273190)

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