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
  • 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 2, 2022

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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 finalpart34702/03/2020
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    G Production Inc.251676961manufacture(0299-4103)
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