WITCH HAZEL READYINCASE (WITCH HAZEL) LIQUID [P & L DEVELOPMENT, LLC]

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WITCH HAZEL READYINCASE (WITCH HAZEL) LIQUID [P & L DEVELOPMENT, LLC]
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NDC 49580-0390-6
Set ID 1588244a-c9e8-4a04-b605-10e35c225e6c
Category HUMAN OTC DRUG LABEL
Packager P & L Development, LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • Active ingredient

    Witch hazel 86%

  • Purpose

    Astringent

  • Uses

    • for relief of minor skin irritations due to:
      • insect bites
      • minor cuts
      • minor scrapes
  • Warnings

    • for external use only
    • avoid swallowing

    When using this product

    • avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if

    condition worsens or symptoms persist for more than 7 days.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    apply to the affected area as often as necessary.

  • Other information

    • keep tightly closed
    • store at room temperature
  • Inactive ingredient

    alcohol 14% by volume

  • Principal Display Panel

    Distilled extract of

    Witch Hazel

    Astringent

    alcohol 14% by volume

    Manufactured by:

    PL Developments

    1874 Hwy 72 W

    Clinton, SC 29325

    Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

    FL OZ(mL

  • Package Label

    Witch hazel 86%

    ReadyInCase Witch Hazel Liquid

  • INGREDIENTS AND APPEARANCE
    WITCH HAZEL  READYINCASE
    witch hazel liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0390
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL86 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49580-0390-6473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34708/31/2014
    Labeler - P & L Development, LLC (101896231)
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