Label: ATTENDS ADVANCED BARRIER- zinc oxide spray

  • 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 6, 2014

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient                                        Purpose

    Zinc Oxide 10% ................................. Skin Protectant

  • PURPOSE

    Attends Professional Care

    Prevents. Treats. Protects. 3in1

    Attends Advanced Barrier S[ray

    Zinc Oxide Skin Protectant

    Recommended for use on irritated or chafed skin

    Convenient and easy to use Pump Spray

    • No rubbing
    • No staining
    • No stinging

    (Spanish Panel)

    • Prevents diaper rash
    • Treats irritated, chafed skin
    • Provides protective barrier to help keep skin drier

    (Spanish Section

    Dermatologically Tested

    Net Wt. 3.5 oz (99.2 g)

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. 

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    Uses

    • Helps treat diaper rash
    • Protects chafed skin due to diaper rash
    • Helps protect skin for wetness
  • WARNINGS

    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
  • DOSAGE & ADMINISTRATION

    Directions

    • Cleanse the diaper area and allow to dry
    • Shake bottle well before every use
    • Change wet and soiled diapers promptly
    • Spray 4-6 inches from skin. No rub in is required
    • Apply product liberally as often as necessary, with each dipaer change, especially at bedtime or any time exposure to wet diapers may be prolonged
  • OTHER SAFETY INFORMATION

    Other Information

    • Store between 59-77oF (15-25oC)
    • Lot No & Exp date: see bottom of bottle

    Questions? Call 1-800-428-8363

    Manufactured in Belgium

    Distributed by: 

    Attends Healthcare Products, Inc.

    Greenville, NC 27834

    www.Attends.com

  • INACTIVE INGREDIENT

    Inactive Ingredients

    aloe barbadensis gel, aqua, C12-15 alkyl benzoate, caprylic/capric triglyceride, cera alba, coco-caprylate/caprate, diazolidinyl urea, glycerin, L-Carnoside, magnesium sulfate, panthenol, paraffinum liquidum, parfum, PEG-30 dipolyhydroxystearate, potassium sorbate, silica, sodium benzoate, tocopherol, zinc oxide.

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    ATTENDS ADVANCED BARRIER 
    zinc oxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62450-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 g  in 99 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62450-002-0199 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/06/2014
    Labeler - Purna Pharmaceuticals NV (372126946)
    Establishment
    NameAddressID/FEIBusiness Operations
    Purna Pharmaceuticals NV372126946manufacture(62450-002)