Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID d75c073d-04d5-465f-bab8-0db0945e568a
Route
TOPICAL
Published
Effective Date 2011-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (3 g)
Inactive Ingredients
Water Glycerin Helianthus Annuus Glyceryl Laurate Soybean Oil Cetostearyl Alcohol Dexpanthenol Polyoxyl 20 Cetostearyl Ether Medium-chain Triglycerides Sorbitol Ricinoleic Acid Rosemary Oil Alpha-tocopherol Squalane .alpha.-bisabolol, (+/-)- Carrageenan Sodium Starch Glycolate Type A Potato Green Tea Leaf Triticum Aestivum Pollen Cat's Claw Hyaluronate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-06-13

Description

Allantoin (0.5%)

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Allantoin (0.5%)

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

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

Active Ingredient

Allantoin (0.5%)



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







Keep Out of Reach of Children

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


Structured Label Content

Uses

Temporarily protects minor: burns, cuts, and scrapes

Temporarily protects and helps relieve
  • chapped skin

  • cracked skin



   

Purpose

Skin protectant

Warnings

For external use only

When using this product

  • do not get into eyes

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

Active Ingredient (Active ingredient)

Allantoin (0.5%)



Inactive Ingredients (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 (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







Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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