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

La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic Multipurpose by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic Multipurpose by is a Otc medication manufactured, distributed, or labeled by 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 THERAPEUTIC MULTIPURPOSE 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69625-743
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: 69625-743-01	1 in 1 CARTON	03/15/2021
1		40 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69625-743-02	1 in 1 CARTON	03/15/2021
2		3 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 69625-743-03	1 mL in 1 PACKET; Type 0: Not a Combination Product	03/15/2021
4	NDC: 69625-743-04	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 - Cosmetique Active Production (282658798)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetique Active Production		282658798	manufacture(69625-743)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA PRODUCTS, INC.		624244349	pack(69625-743)