Label: CETAPHIL BABY SOOTHE AND PROTECT CREAM- allantoin cream

  • NDC Code(s): 0299-4103-05
  • Packager: Galderma Laboratories, L.P.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 22, 2023

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  • 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 ■Helps protect from the drying
    effects of wind and cold weather.

  • 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

    BUTYROSPERMUM PARKII (SHEA) OIL, CALENDULA OFFICINALIS FLOWER EXTRACT, CAPRYLYL/CAPRYL GLUCOSIDE, CAPRYLYL GLYCOL, 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

    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

  • PRINCIPLE DISPLAY PANEL - 6 oz tube

    #1 Doctor Recommended
    Sensitive Skincare Brand

    Cetaphil®

    baby

    Soothe & Protect
    Cream
    with Allantoin -
    Skin Protectant

             

    Baby's Sensitive Skin

    Protects baby's delicate skin 
    and prevents dry, chafed or
    cracked skin

    Soothing calendula


    (SEAL) Dermatologist tested

    NET WT 6 oz (170 g)

    P55465-1 Cet Baby SootheProtect Cream 6oz Tube final
  • INGREDIENTS AND APPEARANCE
    CETAPHIL BABY SOOTHE AND PROTECT CREAM 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4103
    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
    Sheanut Oil (UNII: O88E196QRF)  
    Calendula Officinalis Flower (UNII: P0M7O4Y7YD)  
    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:0299-4103-05170 g in 1 TUBE; Type 0: Not a Combination Product02/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01602/03/2020
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    G Production Inc.251676961manufacture(0299-4103)
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