INFLAMMATION OTC- allantoin lotion

Inflammation OTC by

Drug Labeling and Warnings

Inflammation OTC by is a Otc medication manufactured, distributed, or labeled by Skin Deep. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

INFLAMMATION OTC   RADIATION RELIEF
allantoin lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45156-5616
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z)	Allantoin	3 g  in 600 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45156-5616-2	1 in 1 BOX
1	NDC: 45156-5616-1	29 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/13/2010

Labeler - Skin Deep (833276566)

Establishment
Name	Address	ID/FEI	Business Operations
Skin Deep		833276566	manufacture