Miracle Heel Repair
FDA Label NDC 66391-0604

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Winning Solutions for the product Miracle Heel Repair (NDC 66391-0604). 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, warnings, otc - keep out of reach of children, dosage & administration, indications & usage, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient : Allantoin 1.0 % , Dimethicone 1.0 %

Otc - Purpose

Purpose : Skin Protectant


Warnings

Warnings: For external use only .

Otc - Keep Out Of Reach Of Children

Keep out of reach of children : In case of accidental ingestion, get medical help or contact a Poison Control center right away.


Dosage & Administration

Directions :  adults and  children 2 years and older apply as needed

                      under 2 years ask a doctor.

                      wash and dry skin apply liberatly over attached area and massage until absorbed .





Indications & Usage

Uses: Temporary protects and helps relieve chapped or cracked skin


Inactive Ingredient

Aloe barabardensis leaf Juice , water , PEG 8, stearic acid , PEG-100 stearte , glyceryl stearate , cetearyl alcohol, polysorbate 60 , propylene glycol, mineral oil ,hydrogenated polyisobutene,cetyl alcohl , butyrospermum parkii (shea butter) , theobroma cacao (cocoa) seed butter , triethanolamine, mangifera indica (mango) seed butter, salicylic acid ,chondrus crispis (carageenan) , arthemis nobilis flower extract, fragrance, methylparaben, propylparaben,  tetrasodium edta , bht, diazolidinyl urea

Package Label.Principal Display Panel

 

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