SARENE SOOTHING SKIN (ALLANTOIN) STICK [BEEKLEY CORPORATION]

SARENE SOOTHING SKIN (ALLANTOIN) STICK [BEEKLEY CORPORATION]
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NDC 52319-001-13
Set ID 362ff4ef-e3e6-40a7-a654-3f3c49d1e3d8
Category HUMAN OTC DRUG LABEL
Packager Beekley Corporation
Generic Name
Product Class
Product Number
Application Number PART347
  • 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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