Poison Oak And Ivy
FDA Label NDC 57479-102

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Demartini Spring Hill Pharmacy, Inc. for the product Poison Oak And Ivy (NDC 57479-102). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

PURPOSE

EXTERNAL ANALGESIC

ASTRINGENT

Indications & Usage

USES: POISON OAK, POISON SUMAC, POISON IVY, MOSQUITO BITES, OTHER ALLERGIC RASHES.

Warnings

WARNINGS: FOR EXTERNAL USE ONLY. DO NOT USE ON EEP OR PUNCTURE WOUNDS, ANIMAL BITES, OR SERIOUS BURNS.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP ORCONTACT A POISON CONTROL CENTER RIGHT AWAY.

Dosage & Administration

DIRECTIONS FOR USE: APPLY DIRECTLY TO THE RASH AREA 3 TO 5 TIMES DAILY OR AS NEEDED FOR THE RELIEF OF ITCHING, REDNESS OR WEEPING.

Inactive Ingredient

INACTIVE INGREDIENTS: SD Alcohol 40-B, Aqua, Witch Hazel Distillate, Alcohol (Ethanol-Natural Grain USP), Acrylates/C10-30, Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, *CO Aloe Vera Leaf Powder, Citrus Limon (Lemon) Peel Oil, Benzyl Alcohol, Blue 1 *CO certified organic

Otc - When Using

When using this product
• Avoid getting in eyes or mucus membranes. If contact occurs rinse thoroughly with water.
• Discontinue use if allergic to any of the components.

Otc - Stop Use

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 - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a health professional before use.

Package Label.Principal Display Panel

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