LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST BALM B5 SOOTHING THERAPEUTIC MULTIPURPOSE- dimethicone cream 
L'Oreal USA Products Inc

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Drug Facts

Active ingredient

Dimethicone 1%

Purpose

Skin protectant

Uses

Warnings

For external use only

Do not use

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

For diaper rash:

Other information

● store at room temperature

Inactive ingredients

water, hydrogenated polyisobutene, glycerin, butyrospermum parkii (shea) butter, panthenol, aluminum starch octenylsuccinate, butylene glycol, propanediol, cetyl PEG/PPG-10/1 dimethicone, trihydroxystearin, zinc gluconate, madecassoside, manganese gluconate, silica, aluminum hydroxide, magnesium sulfate, disodium EDTA, copper gluconate, citric acid, acetylated glycol stearate, polyglyceryl-4 isostearate, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, sodium benzoate, phenoxyethanol, chlorhexidine digluconate, titanium dioxide

Questions or comments?

1-888-LRP-LABO  1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

image of a carton

image of a carton
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST BALM B5 SOOTHING THERAPEUTIC MULTIPURPOSE 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-744
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
GLYCERIN (UNII: PDC6A3C0OX)  
SHEA BUTTER (UNII: K49155WL9Y)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PROPANEDIOL (UNII: 5965N8W85T)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
MADECASSOSIDE (UNII: CQ2F5O6YIY)  
MANGANESE GLUCONATE (UNII: 9YY2F980SV)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
COPPER GLUCONATE (UNII: RV823G6G67)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ACETYLATED GLYCOL STEARATE (UNII: K71M6R9N7E)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-744-011 in 1 CARTON03/15/2021
140 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:49967-744-021 in 1 CARTON03/15/2021
23 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:49967-744-031 mL in 1 PACKET; Type 0: Not a Combination Product03/15/2021
4NDC:49967-744-041 in 1 CARTON01/01/2023
4100 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01603/15/2021
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetique Active Production282658798manufacture(49967-744)
Establishment
NameAddressID/FEIBusiness Operations
L'OREAL USA PRODUCTS, INC.624244349pack(49967-744)

Revised: 12/2023
Document Id: 4b40ba80-782a-4973-bc54-46f4000fcf87
Set id: 805cd262-2689-4818-8fed-ddefacbdde23
Version: 4
Effective Time: 20231211
 
L'Oreal USA Products Inc