LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST DEFENSE B5- glycerin gel 
Cosmetique Active Production

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

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

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

image of a carton

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST DEFENSE B5 
glycerin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69625-587
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69625-587-011 in 1 CARTON01/01/2023
140 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:69625-587-021 in 1 CARTON01/01/2023
23 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01601/01/2023
Labeler - Cosmetique Active Production (282658798)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetique Active Production282658798manufacture(69625-587) , pack(69625-587)

Revised: 8/2023
Document Id: e0d158b8-fca9-430b-960c-2e8f6ed0d4ea
Set id: 01c8a0d5-bcd1-4639-be45-530a226401f0
Version: 1
Effective Time: 20230821
 
Cosmetique Active Production