Inflammation Otc
FDA Label NDC 45156-5616

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Skin Deep for the product Inflammation Otc (NDC 45156-5616). 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, keep out of reach of children, directions, inactive ingredients, questions or comments, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Allantoin (0.5%)


Purpose

Skin protectant

Uses

Temporarily protects minor: burns, cuts, and scrapes

Temporarily protects and helps relieve
  • chapped skin
  • cracked skin

  •    

Warnings

For external use only

When using this product

  • do not get into eyes

Keep Out Of Reach Of Children

In case of accidental ingestion seek professional assistance or contact a poison control center immediately.

Directions

  • Apply as needed
  • 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

Inactive Ingredients

water, glycerin, helianthus annuus (sunflower) seed oil, glyceryl laurate, glycine soja (soybean) oil, cetearyl alcohol, panthenol, ceteareth 20, caprylic/capric triglyeride, sorbitol, cetyl ricinoleate, rosmarinus officinalis (rosemary) leaf, tocopherol, squalane, bisabolol, C10-30 cholesterol/lanosterol esters, algae extract,sodium carboxymethly starch, camelia sinensis leaf extract, triticum vulgare (wheat) germ extract, uncaria tomentosa extract, sodium hyaluronate, calendula officinalis flower extract, yeast extract, lavandula angustifolia (lavender) oil, lactobacillus/bean seed extract/sodium glutamate ferment filtrate, petasites japonicus (butterbur) root extract, glycine soja (soybean) seed extract, phytosphingosine HCl, cholesterol, sodium lauroyl lactylate, carbomer, ceramide 3, saccharide isomerate, ceramide 6, ceramide 1, foeniculum vulgare (fennel) fruit extract, saccharomyces/copper ferment, saccharomyces/manganese ferment, saccharomyces/zinc ferment, xanthan gum, glycereth-7 trimethyl ether, phenoxyethanol, iodopropynyl butylcarbmate

Questions Or Comments

call 1-912-236-9430 weekdays

Principal Display Panel

Inflammation OTC

Radiation Relief

Net wt 1 oz. (28.35 mL)

Manufactured by SkinDeep for SkinFit Distributors

Savannah, GA 31405

Tel: 912-236-9430

www.mwlabs.com


Inflammation Otc Box (Radiation Relief Box)

Inflammation Otc Box (Radiation Relief Box)



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