INFLAMMATION OTC  RADIATION RELIEF- allantoin lotion 
Skin Deep

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.

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Drug Facts

Active ingredient

Allantoin (0.5%)


Purpose

Skin protectant

Uses

Temporarily protects minor: burns, cuts, and scrapes

Temporarily protects and helps relieve
   

Warnings

For external use only

When using this product

Keep out of reach of children

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

Directions

Stop use and ask a doctor if

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


INFLAMMATION OTC   RADIATION RELIEF
allantoin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45156-5616
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin3 g  in 600 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Helianthus Annuus (UNII: BKJ0J3D1BP)  
Glyceryl Laurate (UNII: Y98611C087)  
Soybean Oil (UNII: 241ATL177A)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Dexpanthenol (UNII: 1O6C93RI7Z)  
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Sorbitol (UNII: 506T60A25R)  
Ricinoleic Acid (UNII: I2D0F69854)  
Rosemary Oil (UNII: 8LGU7VM393)  
Alpha-Tocopherol (UNII: H4N855PNZ1)  
Squalane (UNII: GW89575KF9)  
.Alpha.-Bisabolol, (+/-)- (UNII: 36HQN158VC)  
Carrageenan (UNII: 5C69YCD2YJ)  
Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)  
Green Tea Leaf (UNII: W2ZU1RY8B0)  
Triticum Aestivum Pollen (UNII: F1KAH8374D)  
Cat's Claw (UNII: 9060PRM18Q)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45156-5616-21 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/FEIBusiness Operations
Skin Deep833276566manufacture

Revised: 1/2011
Document Id: 2b840267-8a9f-4168-a63f-0b1d67647932
Set id: d75c073d-04d5-465f-bab8-0db0945e568a
Version: 4
Effective Time: 20110116
 
Skin Deep