Label: PREMIERPRO FLUSHABLE WIPES WITH DIMETHICONE- dimethicone swab

  • 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 January 9, 2018

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  • Drug Facts

  • Active Ingredient

    Dimethicone  3.2%

    Purpose

    Skin Protectant

  • Uses:

    Helps treat and prevent diaper rash. Protects chafed skin associated with diaper rash and helps protect from wetness. Temporarily protects and helps relieve chapped or cracked skin.

  • Warnings:

    For external use only.

    • Avoid contact with the eyes​

    Stop use

    and contact a physician if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children

    If swallowed, get medical help or contact Poison Control Center right away.

    Do not use:

    • On deep or puncture wounds • Animal bites • Serious burns

  • Directions:

    Pull back label and remove wipes

    • Thoroughly cleanse soiled area, using one wipe at a time

    •Use as often as necessary

    •Dispose of cloths in a waste receptacle

    •Do not flush

    Heating Instructions:

    • Wipes may be used at room temperature but if heating is desired, wipes may be warmed in a wipes warmer. Wipes should be warmed:

    • in a single warming session at temperatures not exceeding 52°C (125°F) and

    • for a maximum of 4 days. Discard wipes that have been:

    • Exposed to warming temperatures exceeding 52C (125F); or

    • Stored longer than 4 days within the warmer; or

    • Been warmed, allowed to cool, and then re-warmed.

  • Other Information:

    •When not in a warmer, store between 15-30˚C (59-86˚F)

  • Inactive Ingredients:

    Allantoin, Aqua, 2-Bromo-2-Nitropropane-1, 3-Diol, Chlorphenesin, Decyl Glucoside, Glycerin, Polyaminopropyl Biguanide, Polysorbate 20, Propylene Glycol, Sodium Citrate

  • Package Labeling:

    24pack

  • INGREDIENTS AND APPEARANCE
    PREMIERPRO FLUSHABLE WIPES WITH DIMETHICONE 
    dimethicone swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61312-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE32 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61312-010-0124 in 1 CASE07/13/2017
    1216 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/13/2017
    Labeler - HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD. (526890634)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD.526890634manufacture(61312-010)
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