Inflammation OTC Radiation Relief

Dosage form: lotion
Ingredients: Allantoin 3g in 600g
Labeler: Skin Deep
NDC Code: 45156-5616

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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   RADIATION RELIEF
allantoin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45156-5616
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (Allantoin) Allantoin3 g  in 600 g
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:45156-5616-21 TUBE (TUBE) in 1 BOX
1NDC:45156-5616-129 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/13/2010
Labeler - Skin Deep (833276566)
Establishment
NameAddressID/FEIOperations
Skin Deep833276566manufacture

Revised: 01/2011
 
Skin Deep

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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