LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST DEFENSE B5 SKIN PROTECTANT- glycerin gel

La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Cosmetique Active Production. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Glycerin 21%

Purpose

Skin protectant

Uses

• temporarily protects and helps relieve chapped or cracked skin

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

Other information

● store at room temperature

Inactive ingredients

water, dimethicone, panthenol, pentylene glycol, c30-45 alkyl dimethicone, polybutene, sodium citrate, PEG/PPG-18/18 dimethicone, citric acid, dimethiconol, polysorbate 20, madecassoside, caprylyl glycol, sodium hyaluronate, zinc gluconate, copper gluconate, manganese gluconate, tocopherol

Questions or comments?

1-888-LRP-LABO  1-888-577-5226

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST DEFENSE B5 SKIN PROTECTANT 
glycerin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-586
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PANTHENOL (UNII: WV9CM0O67Z)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
MADECASSOSIDE (UNII: CQ2F5O6YIY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
COPPER GLUCONATE (UNII: RV823G6G67)
MANGANESE GLUCONATE (UNII: 9YY2F980SV)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-586-01	1 in 1 CARTON	01/01/2023
1		40 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-586-02	1 in 1 CARTON	01/01/2023
2		3 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	01/01/2023

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetique Active Production		282658798	manufacture(49967-586) , pack(49967-586)