Itch Relief
FDA Label NDC 59262-401

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Similasan Corporation for the product Itch Relief (NDC 59262-401). 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 active ingredient, purpose, uses:, warnings:, if pregnant or breast feeding,, keep out of reach of children., directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Apis mellifica 12X

Lachesis mutus 12X

Ledum palustre 6X

Urtica urens 8X

Purpose

stinging, pain, redness, burning

burning, skin discoloration

itching, skin irritation

itching, burning, skin irritation and rashes

Uses:

According to homeopathic principles, the active ingredients in this product temporarily relieve pain and itching associated with insect bites & stings and minor skin irritations due to poison ivy, oak & sumac.

Warnings:

  • For external use only.
  • Initial exacerbation of symptoms may occur.
  • Avoid contact with the eyes.
  • If conditions worsen or persist for more than 72 hours discontinue use and consult a physician.

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 right away.

Directions:

For adults and children age 2 and over: Moisten the affected area with roller ball at short intervals several times a day until the symptoms clearly diminish. Continue to apply 3-6 times daily until the affected area is completely healed.

Other Information:

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients:

Alcohol, 40%, Vegetable glycerin

Questions?

Reach our representatives at 1-800-240-9780 or [email protected].

www.SimilasanUSA.com

Principal Display Panel

NDC 59262-401-42
Similasan®
Itch Relief  
ROLL-ON
7.5 mL/0.25 fl oz

Principal Display Panelndc 59262-401-42similasan®itch Relief Roll-on7.5 mL/0.25 Fl Oz (Itch Relief 01)

Principal Display Panelndc 59262-401-42similasan®itch Relief Roll-on7.5 mL/0.25 Fl Oz (Itch Relief 01)

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