Label: RUGID ITCH AND PAIN RELIEF- diphenhydramine hydrochloride and zinc acetate liquid

  • NDC Code(s): 59555-010-18, 59555-010-19
  • Packager: R & R Lotion, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 14, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Diphenhydramine HCL 2%Topical Analgesic
    Zinc Acetate 0.1%Skin Protectant
  • Uses

    Temporary relieves pain and itching associated with: Insect Bites

    • Minor Burns
    • Minor Cuts
    • Sunburn
    • Minor Skin Irritations
    • Scrapes
    • Dries oozing and weeping of Poison Ivy, Poison Oak, and Poison Sumac
    • Rashes due to Poison Ivy, Poison Oak, and Poison Sumac.
  • Warnings

    For external use only. Do not use on large areas of the body

    • with any other product containing diphenhydramine, even one taken by mouth.

    Ask doctor before use on chicken pox

    • on measles

    When using this product avoid contact with eyes

    Stop use and ask doctor if conditions worsen, or do not improve within 7 days

    • symptoms persist for 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.

  • Directions

    Do not use more than directed

    • Hold stick stright down over infected area
    • press tip of stick repeatedly on affect skin area until liquid flows, then dab sparingly
    • adults and children 2 years of age and older: apply to affected area not more then 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • Other Information

    Protect from excessive heat (40ºC/104ºF)

  • Inactive Ingredients

    Propylene Glycol, Xanthan Gum, DI Water, PVP K-30

  • Questions or Comments?

    1-888-860-7424

  • PRINCIPAL DISPLAY PANEL - 20 ML Bottle Label

    R&R LOTION INC.

    RUGID
    OUTDOORS
    EST. 84

    ITCH
    & PAIN
    RELIEF
    STICK

    MINOR CUTS,
    BITES & BURNS

    USA

    .76 FL. OZ. (20ML) e

    Peel
    Here

    PRINCIPAL DISPLAY PANEL - 20 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    RUGID ITCH AND PAIN RELIEF 
    diphenhydramine hydrochloride and zinc acetate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 mL
    Zinc Acetate (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) Zinc Acetate1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59555-010-181 mL in 1 PACKET; Type 0: Not a Combination Product05/01/2019
    2NDC:59555-010-1920 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34805/01/2019
    Labeler - R & R Lotion, Inc (062979000)
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