Inflammation OTC Bruise Relief

Dosage form: lotion
Ingredients: Camphor (Natural) 32g in 1000g
Labeler: Skin Deep
NDC Code: 45156-5502

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

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

INFLAMMATION OTC  BRUISE RELIEF
camphor lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45156-5502
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Camphor (Natural) (Camphor (Natural)) Camphor (Natural)32 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Alcohol 
Dexpanthenol 
Soybean Oil 
Ascorbic Acid 
Lemon Oil 
Lecithin, Soybean 
Niacinamide 
Cat's Claw 
Calendula Officinalis Flower 
Wormwood 
Green Tea Leaf 
Arnica Montana Flower 
Xanthan Gum 
Carrageenan 
Ginger 
Alpha-Tocopherol 
Urea 
Saccharomyces Cerevisiae 
Arctium Lappa Root 
Trideceth-6 
Ruscus Aculeatus Root 
Betaine 
Inositol 
Taurine 
Trehalose 
Phytonadione 
Iodopropynyl Butylcarbamate 
Phenoxyethanol 
Packaging
#Item CodePackage Description
1NDC:45156-5502-21 TUBE (TUBE) in 1 BOX
1NDC:45156-5502-129 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34808/08/2011
Labeler - Skin Deep (833276566)
Establishment
NameAddressID/FEIOperations
Skin Deep833276566manufacture

Revised: 08/2011
 
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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