LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST BALM B5 SOOTHING THERAPEUTIC MULTIPURPOSE- dimethicone cream

La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Cosmetique Active Production, L'OREAL USA PRODUCTS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Dimethicone 1%

Purpose

Skin protectant

Uses

• temporarily protects and helps relieve chafed, chapped or cracked skin
• helps protect from the drying effects of wind and cold weather
• helps treat and prevent diaper rash
• protects chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only

Do not use

• on deep or puncture wounds
• animal bites
• serious burns

When using this product

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 as needed

For diaper rash:

• change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
• apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST BALM B5 SOOTHING THERAPEUTIC MULTIPURPOSE 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-744
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-744-01	1 in 1 CARTON	03/15/2021
1		40 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-744-02	1 in 1 CARTON	03/15/2021
2		3 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 49967-744-03	1 mL in 1 PACKET; Type 0: Not a Combination Product	03/15/2021
4	NDC: 49967-744-04	1 in 1 CARTON	01/01/2023
4		100 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	03/15/2021

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetique Active Production		282658798	manufacture(49967-744)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA PRODUCTS, INC.		624244349	pack(49967-744)