Label: SARENE SOOTHING SKIN- allantoin stick

  • 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 April 10, 2010

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  • SPL UNCLASSIFIED SECTION

  • Active Ingredient:

    Allantoin 0.5%

  • Purpose:

    Skin Protectant

  • Uses:

    • helps prevent and helps relieve chafed, chapped or cracked skin
    • temporarily protects minor cuts, scrapes, burns
  • 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 Poison Control Center right away.

  • Directions

    Apply as needed.

    Other Information

    • Store at 59º – 86º F (15º - 30º C)
    • may stain some fabrics
  • Inactive Ingredients

    aloe barbadensis (aloe vera) leaf juice, C18-36 acid triglycerides, caprylic/capric triglycerides, tocopheryl acetate, tribehenin

  • Questions

    +1 (800) 233-5539

    Distributor:
    Beekley Corporation, Bristol, CT
    Made in Canada

  • PRINCIPAL DISPLAY PANEL

    BEEKLEY
    Sarene™
    SOOTHING SKIN STICK
    helps prevent and relieve chafing
    for skin made sensitive by radiation
    dry, non-greasy,
    invisible skin lubricant.
    no mess, no scent!
    balm
    NET WT. 1.3 oz (36.9 g)

    Principal Display Panel Sarene Soothing Skin Stick

  • INGREDIENTS AND APPEARANCE
    SARENE SOOTHING SKIN 
    allantoin stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52319-001
    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)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52319-001-131 in 1 BOX
    136.9 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34704/19/2010
    Labeler - Beekley Corporation (001157841)
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