INFLAMMATION OTC BRUISE RELIEF- camphor 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

Camphor (3.16%)

Purpose

Counterirritant

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with bruises

Warning

For external use only

Avoid contact with the eyes

If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician

Do not apply to wounds or damaged skin

Do not bandage tightly

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

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: Consult a physician

Inactive Ingredients

water, glycine soja (soybean) oil, glycerin, panthenol, alcohol, ascorbic acid, citrus medica limonum (lemon) peel extract, niacinamide, petasites japonicus (butterbur) root extract, glycereth-7 trimethyl ether, sodium polycrylate, c18-21 alkane, lactobacillus/bean seed extract/sodium glutamate ferment filtrate, uncaria tomentosa extract, calendula officinale (ginger) root extract, tocopherol, urea, yeast amino acid, arctium majus root (burdock) extract, trideceth-6, ruscus aculeatus root extract, inositol, taurine, trehalose, centipeda cunninghamii extract, saccharomyces/calcium ferment, saccharomyces/copper ferment, saccharomyces/manganese ferment, saccaromyces/zinc ferment, vitamin k, iodopropynyl butylcarbamate, phenoxyethanol

Questions and Comments

Store between 35 F and 80 F

call 1-912-236-9430 weekdays

Principal Display Panel

Inflammation OTC

Bruise Relief

Net wt 1 oz. (28.5 mL)

Manufacture by SkinDeep for SkinFit Distributors

Savannah, Georgia 31405

Tel: 912-236-9430

www.mwlabs.com

INGREDIENTS AND APPEARANCE

INFLAMMATION OTC  BRUISE RELIEF
camphor lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45156-5502
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Camphor (Natural) (UNII: N20HL7Q941) (Camphor (Natural) - UNII:N20HL7Q941)	Camphor (Natural)	32 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Alcohol (UNII: 3K9958V90M)
Dexpanthenol (UNII: 1O6C93RI7Z)
Soybean Oil (UNII: 241ATL177A)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Lemon Oil (UNII: I9GRO824LL)
Lecithin, Soybean (UNII: 1DI56QDM62)
Niacinamide (UNII: 25X51I8RD4)
Cat's Claw (UNII: 9060PRM18Q)
Calendula Officinalis Flower (UNII: P0M7O4Y7YD)
Wormwood (UNII: F84709P2XV)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Arnica Montana Flower (UNII: OZ0E5Y15PZ)
Xanthan Gum (UNII: TTV12P4NEE)
Carrageenan (UNII: 5C69YCD2YJ)
Ginger (UNII: C5529G5JPQ)
Alpha-Tocopherol (UNII: H4N855PNZ1)
Urea (UNII: 8W8T17847W)
Saccharomyces Cerevisiae (UNII: 978D8U419H)
Arctium Lappa Root (UNII: 597E9BI3Z3)
Trideceth-6 (UNII: 3T5PCR2H0C)
Ruscus Aculeatus Root (UNII: ZW12V95I1Q)
Betaine (UNII: 3SCV180C9W)
Inositol (UNII: 4L6452S749)
Taurine (UNII: 1EQV5MLY3D)
Trehalose (UNII: B8WCK70T7I)
Phytonadione (UNII: A034SE7857)
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)
Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45156-5502-2	1 in 1 BOX
1	NDC: 45156-5502-1	29 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	08/08/2011

Labeler - Skin Deep (833276566)

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