Ivy-dry Super Spray
FDA Label NDC 49546-106

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ivy-dry, Inc. for the product Ivy-dry Super (NDC 49546-106). 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 ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Benzyl Alcohol 10%

Camphor 0.5%

Menthol 0.25%


Purpose

External Analgesic


Uses

  • for the temporary relief of itching associated with insect bites and minor skin irritations

Warnings

For external use only.

Do Not Use

  • on face or genital areas
  • on areas of blistered or broken skin
  • with a compress after application

When Using This Product

  • do not get into eyes
  • if contact occurs, flush eyes with water

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.

If Pregnant Or Breast-Feeding,

ask a doctor before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

  • Apply to affected area not more than 3 times daily.
    • Children under 6 years of age: do not use, ask a doctor.
    • Severe reactions to Urushiol (the chemical released by the plant, which causes the irritation) can look like chemical burns and have a thick leathery appearance. Additional applications may be necessary.
    • Test product on small patch of skin before applying to the entire body.

Other Information

Store at room temperature

You may report a serious adverse reaction to Report Reaction LLC, PO Box 22, Plainsboro, NJ 08536-0222


Inactive Information

WATER, ISOPROPANOL, ZINC ACETATE, ISOCETETH-20, ZINC LACTATE

Package Labeling


Ivy-Dry Super

TEMPORARY RELIEF OF PAIN AND ITCHING
Associated with Minor Skin Irritations and Insect Bites

External Analgesic


Manufactured in the USA for:
Ivy-Dry, Inc.
299-B Fairfield Avenue
Fairfield, NJ 07070

©2012 Ivy-Dry, Inc.

Questions or Comments www.ivydry.com



Ivy-dry Super (Ivydryspraypump)

Ivy-dry Super (Ivydryspraypump)

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