CERAVE DEVELOPED WITH DERMATOLOGISTS THERAPEUTIC HAND- dimethicone cream 
L'Oreal USA Products Inc

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Drug Facts

Active ingredient

Dimethicone 1%

Purpose

Skin protectant

Use

helps prevent and temporarily protects chafed, chapped or cracked skin

Warnings

For external use only

Do not use on

When using this product

do not get into eyes

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply as needed

Inactive Ingredients

water, cyclopentasiloxane, aluminum/magnesium hydroxide stearate, cyclohexasiloxane, niacinamide, sodium chloride, polyglyceryl-4 isostearate, cetyl PEG/PPG-10/1 dimethicone, hexyl laurate, phenoxyethanol, ceramide NP, ceramide AP, ceramide EOP, carbomer, methylparaben, sodium lauroyl lactylate, cholesterol,. Propylparaben, hydrolyzed hyaluronic acid, phytosphingosine, xanthan gum, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate

Questions or comments?

Toll-free number 1-888-768-2915

www.cerave.com

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CERAVE DEVELOPED WITH DERMATOLOGISTS THERAPEUTIC HAND 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-925
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CERAMIDE 6 II (UNII: F1X8L2B00J)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
HYALURONIC ACID (UNII: S270N0TRQY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-925-011 in 1 CARTON12/12/201712/01/2023
185 g in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49967-925-025 g in 1 TUBE; Type 0: Not a Combination Product12/12/201712/01/2023
3NDC:49967-925-031 in 1 CARTON12/12/2017
385 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01612/12/2017
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA Products, Inc.624244349MANUFACTURE(49967-925) , pack(49967-925)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, LLC071609663manufacture(49967-925)

Revised: 12/2023
Document Id: 26ac7b9e-562d-48c3-a4dc-838a751e975e
Set id: 7fe49112-4180-415c-a380-768a8d6b2185
Version: 5
Effective Time: 20231228
 
L'Oreal USA Products Inc