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Inflammation OTC Deep Pain Care Cold

Dosage form: lotion
Ingredients: Camphor (Natural) 18g in 600g, Menthol 16g in 600g
Labeler: Skin Deep
NDC Code: 45156-5610

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 (3.0%)

Menthol (2.6%)

Purpose

Topical Analgesic

Counterirritant

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings

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

In case of accidental ingestion seek professional assistance or contact a poison control 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, dimethyl sulfone, glycerin, glycine soja (soybean) oil, eucalyptus globulus oil, piper nigrum (pepper) seed extract, centipedia cunninghamii extract, arctium majus root (burdock) extract, mentha piperita (peppermint) leaf extract, artemisia absinthium, uncaria tomentosa extract, zingiber officinale (ginger) root oil, arnica montana flower extract, zingiber officinale (ginger) root extract, d-ribose, sodium polycrylate, c18-21 alkane, trideceth-6, tocopherol, phenoxyethanol, iodopropynyl butylcarbamate

Questions or Comments

Store between 35 F and 80 F

call 1-912-236-9430 weekdays

Principal Display Panel

Inflammation OTC

Deep Pain Care Cold

New wt 1.1 oz. (31 mL)

Manufactured by SkinDeep for SkinFit Distributors

Savannah, GA 31405

Tel: 912-236-9430

www.mwlabs.com


INFLAMMATION OTC  DEEP PAIN CARE COLD
camphor, menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45156-5610
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Camphor (Natural) (Camphor (Natural)) Camphor (Natural)18 g  in 600 g
Menthol (Menthol) Menthol16 g  in 600 g
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Dimethyl Sulfone 
Black Pepper Oil 
Soybean Oil 
Arctium Lappa Root 
Peppermint 
Wormwood 
Cat's Claw 
Ginger Oil 
Arnica Montana 
Ginger 
Trideceth-6 
Alpha-Tocopherol 
Phenoxyethanol 
Iodopropynyl Butylcarbamate 
Packaging
#Item CodePackage Description
1NDC:45156-5610-21 TUBE (TUBE) in 1 BOX
1NDC:45156-5610-131 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34808/16/2011
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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