Label: CETAPHIL SOOTHING GEL CREAM- allantoin cream

  • NDC Code(s): 0299-4105-00, 0299-4105-05, 0299-4105-10, 0299-4105-15
  • Packager: Galderma Laboratories, L.P.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 11, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredients......Purpose

    Allantoin 0.5%......Skin Protectant

  • PURPOSE

  • KEEP OUT OF REACH OF CHILDREN

  • Uses

    Temporarily protects minor: ●cuts
    ●scrapes ●burns ■helps prevent and temporarily
    protects and helps relieve chafed, chapped or
    cracked skin

  • Warnings

    For external use only.

    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.

    Do not use on ■Deep or puncture wounds
    ■Animal bites ■Serious burns

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■Apply as needed

  • Inactive Ingredients

    ALOE BARBADENSIS LEAF JUICE POWDER, BUTYROSPERMUM PARKII (SHEA) OIL, CAPRYLYL GLYCOL, CAPRYLYL/CAPRYL GLUCOSIDE, CITRIC ACID, GLYCERIN, GLYCINE SOJA (SOYBEAN) OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, METHYLPROPANEDIOL, PANTHENOL, PANTOLACTONE, PHENOXYETHANOL, POLYISOBUTENE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SORBITAN OLEATE, TOCOPHEROL, WATER

  • Questions or comments?

    1-866-735-4137

  • PRINCIPLE DISPLAY PANEL - 16 OZ jar

    NEW LOOK

    Cetaphil®

    Soothing Gel Cream
    0.5% Allantoin Skin Protectant

    Dry, Irritated Skin

    Fast absorbing gel-cream
    helps relieves and prevent irritated skin.

    Aloe Vera, Vitamin B5

    Dermatologist Recommended
    Sensitive Skin


             

    NET WT 16 OZ (453 g)

    Distributed By:
    Galderma Laboratories, L.P.
    Dallas, TX 75201 USA

    All trademarks are the property of their respective owners.

    Made in Canada.

    cetaphil.com
    P55450-3

    P55450-3 Soothing Gel Cream 16oz
  • INGREDIENTS AND APPEARANCE
    CETAPHIL SOOTHING GEL CREAM 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Sheanut Oil (UNII: O88E196QRF)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Caprylyl/Capryl Oligoglucoside (UNII: E00JL9G9K0)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Soybean Oil (UNII: 241ATL177A)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Methylpropanediol (UNII: N8F53B3R4R)  
    Panthenol (UNII: WV9CM0O67Z)  
    Pantolactone, (R)- (UNII: J288D7O0JS)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Polyisobutylene (1000 Mw) (UNII: 5XB3A63Y52)  
    Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) (UNII: 1DXE3F3OZX)  
    Tocopherol (UNII: R0ZB2556P8)  
    Water (UNII: 059QF0KO0R)  
    Sorbitan Monooleate (UNII: 06XEA2VD56)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4105-0010 g in 1 TUBE; Type 0: Not a Combination Product02/17/2020
    2NDC:0299-4105-0585 g in 1 TUBE; Type 0: Not a Combination Product02/17/2020
    3NDC:0299-4105-10226 g in 1 TUBE; Type 0: Not a Combination Product02/17/2020
    4NDC:0299-4105-15453 g in 1 JAR; Type 0: Not a Combination Product02/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01602/17/2020
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    G Production Inc.251676961manufacture(0299-4105)