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
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated March 28, 2022

If you are a consumer or patient 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 - 8 OZ TUBE

    #1 Doctor Recommended
    Sensitive Skincare Brand

    Cetaphil®

    Soothing
    Gel Cream
    with Aloe

    Irritated, Sensitive Skin

    Fast absorbing formula
    helps rescue, prevent and
    relieve dry, stressed skin

    Skin Protectant Allantoin

    Five Skin Sensitivity Sign

             

    NET WT 8 OZ (226 g)

    Distributed By:
    Galderma Laboratories, L.P.
    Fort Worth, TX 76177 USA

    All trademarks are the property of their respective owners.

    Made in Canada.

    cetaphil.com
    P55452-1

    052229 P55452-1 TUBE Cetaphil Soothing Gel Cream 8oz US (OTC) OL
  • 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 finalpart34702/17/2020
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    G Production Inc.251676961manufacture(0299-4105)