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  5. Label Information: Ivarest

FDA Label for Ivarest

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. PRINCIPAL DISPLAY PANEL - 56G TUBE CARTON

Ivarest Product Label

The following document was submitted to the FDA by the labeler of this product Blistex Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Purpose



Active ingredientsPurpose
Calamine 14.0 % (w/w)Skin protectant
Benzyl Alcohol 10.5 % (w/w)External analgesic
Diphenhydramine Hydrochloride 2.0 % (w/w)External analgesic

Uses



  • for the temporary relief of pain and itching associated with poison ivy, poison oak, poison sumac, insect bites or minor skin irritations.
  • dries the oozing and weeping of poison:
    • ivy
    • oak
    • 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 A Doctor Before Use



  • on chicken pox
  • on measles

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

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • do not use more often than directed
  • as soon as possible after exposure, wash affected area with soap and water (or Ivarest Poison Ivy Cleansing Foam). Gently pat dry.
  • apply Ivarest liberally to form a layer you can not see through.
  • adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Other Information



Avoid contact with clothing. Ivarest may stain certain fabrics.


Inactive Ingredients



bentonite, benzethonium chloride, camphor, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, hydroxyethylcellulose, lanolin alcohol, lanolin oil, magnesium aluminum silicate, menthol, petrolatum, PEG-4, polyglyceryl-3 diisostearate, polysorbate 60, propylene glycol, purified water, PVP, red 33, sorbitan stearate, squalane, yellow 5, yellow 6


Principal Display Panel - 56G Tube Carton



2 Itch Relievers

NDC 10157-9077-1

MAXIMUM STRENGTH
IVAREST®
EXTERNAL ANALGESIC/
POISON IVY, OAK, SUMAC DRYING CREAM

POISON IVY
ITCH RELIEF

8 Hour
Relief

MEDICATED ANTI-ITCH CREAM

Double
Relief
Formula

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