AWAKEN MOISTURIZING CREAM- dimethicone cream

Awaken Moisturizing Cream by

Drug Labeling and Warnings

Awaken Moisturizing Cream by is a Otc medication manufactured, distributed, or labeled by Guangzhou Danting Bath&Body Care Industry Co. Ltd, Medical Group Care, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Dimethicone 5%

PURPOSE

Skin Protectant

DOSAGE & ADMINISTRATION

Skin Protectant

WHEN USING

Avoid direct contact with eyes. If contact occurs rinse
throughly with water.

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Apply liberally as often as needed for supple skin.
Avoid direct contact with eyes. If contact occurs rinse
throughly with water.

STORAGE AND HANDLING

Store in a cool, dark place

INACTIVE INGREDIENT

water, glycerin, dimethicone, petrolatum,
caprylic/capric triglyceride, stearic acid, cetearyl
alcohol, ceteareth-20, steareth-2, phenoxyethanol,
acrylates/c10-30 alkyl acrylate crosspolymer, xanthan
gum, tocopheryl acetate, ethylhexylglycerin, sodium
hyaluronate, disodium EDTA, sodium hydroxide,
ceramide NP, ceramide AP, phytosphingosine,
ceramide EOP, polyglyceryl-10
stearate, phytosterols, stearic acid,
pentylene glycol, aspartic acid, sodium
stearoyl glutamate.

WARNINGS

Avoid direct contact with eyes. If contact occurs rinse
throughly with water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AWAKEN MOISTURIZING CREAM 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75376-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARETH-20 (UNII: YRC528SWUY)
STEARETH-2 (UNII: V56DFE46J5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
XANTHAN GUM (UNII: TTV12P4NEE)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CERAMIDE 1 (UNII: 5THT33P7X7)
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ASPARTIC ACID (UNII: 30KYC7MIAI)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75376-104-16	453 g in 1 BOTTLE; Type 0: Not a Combination Product	08/21/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/21/2025

Labeler - Guangzhou Danting Bath&Body Care Industry Co. Ltd (545337886)

Registrant - Medical Group Care, LLC (085137089)