Ivarest Cream
FDA Label NDC 10157-9077

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blistex Inc for the product Ivarest (NDC 10157-9077). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, do not use, ask a doctor before use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

  • 1Antihistamine
    helps stop the reaction
  • 2Analgesic
    soothes itch fast

    • PLUS Skin protectant to help dry the rash

    Poison Ivy, Oak & Sumac,
    Insect Bites, Minor Skin Irritations

    NET WT 2 OZ(56g)

    Principal Display Panel (56g Tube Carton)

    Principal Display Panel (56g Tube Carton)

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