Label: DERMASIL ADVANCED- dimethicone lotion
- NDC Code(s): 73928-101-01
- Packager: Kingkey MBC Life Technology Group Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 17, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- Use
- Warnings
- DIRECTIONS
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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.
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INGREDIENTS AND APPEARANCE
DERMASIL ADVANCED
dimethicone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73928-101 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 MONOSTEARATE (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) 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) NIACINAMIDE (UNII: 25X51I8RD4) INOSITOL (UNII: 4L6452S749) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73928-101-01 236 mL in 1 TUBE; Type 0: Not a Combination Product 07/17/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/17/2023 Labeler - Kingkey MBC Life Technology Group Co., Ltd. (545349263) Establishment Name Address ID/FEI Business Operations Kingkey MBC Life Technology Group Co., Ltd. 545349263 manufacture(73928-101)