Label: CALDYPHEN CLEAR- pramoxine hydrochloride and zinc acetate lotion

  • 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 June 21, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Pramoxine HCl 1%

  • Purpose

    External analgesic

  • Active Ingredient

    Zinc Acetate 0.1%

  • Purpose

    Skin protectant

  • Uses

    Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, poison oak, and poison sumac and other minor skin irritations.

  • Warnings 

    For External Use Only. Use only as directed. Avoid contact with eye and mucous membranes. ask a doctor before using on children under 2 years of age.

  • Stop use and as a doctor if

    condition worsens. Symptoms last for more than 7 days or celar up and occur again whitin a few days.

  • Keep out of reach of children

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    Adults and children 2 yrs. of age and older. Shake well before using. cleanse the skin with soap and water. Let dry before each use. apply lotion to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.

    children unedr 2 yrs. of age. Consult a doctor before use.

  • Inactive Ingredients

    SD alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, and Purified Water.

  • Other information

    Store at room temperature 15 - 30 (59-86F)

  • SPL UNCLASSIFIED SECTION

    Distributed by: AmerisourceBergen

    1300 Morris Drive, Chesterbrook, PA 19087

  • Questions or comments?

    1-800-662-3435  www.goodneighborpharmacy.com

  • Principal Display Panel

    GNPCaldy.jpg

  • INGREDIENTS AND APPEARANCE
    CALDYPHEN CLEAR 
    pramoxine hydrochloride and zinc acetate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-439
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24385-439-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/28/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2008
    Labeler - Amerisource Bergen (007914906)
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