Inflammation OTC Deep Pain Care Hot

Dosage form: lotion
Ingredients: Camphor (Natural) 4g in 1000g, Capsicum 38g in 1000g, Menthol 17g in 1000g
Labeler: Skin Deep
NDC Code: 45156-5605

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 Fact

Active Ingredient

Camphor (0.46%)

Capsicum Annuum Extract (0.025%)

Menthol (1.7%)

Purpose

Topical Analgesic

Counterirritant

Counterirritant

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
For the temporary relief of pain

Provides warming pain relief

Warnings

For external use only

Avoid contact with the eyes

Do not apply to wounds or damaged skin

Do not bandage tightly

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

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, dimethyl sulfonate, glycerin, glycine soja (soybean) oil, eucalyptus globulus oil, piper nigrum (pepper) seed extract, sodium polycrylate, c18-21 alkane, niacinamide, artemisia absinthium, uncaria tomentosa extract, juniperus communis fruit oil, xanthan gum, zingiber officinate (ginger) root extract, arctium majus root (burdock) extract, arnica montana flower extract, trideceth-6, tocopherol, phenoxyethanol, iodopropynyl butylcarbamate

Questions and Comments

store between 35 F and 80 F

call 1-912-236-9430 weekdays

Principal Display Panel

Inflammation OTC

Deep Pain Care Hot

New wt 1.1 oz. (31 mL)

Manufactured by SkinDeep for SkinFit Distributors

Savannah, GA 31405

Tel: 1-912-236-9430

www.mwlabs.com

INFLAMMATION OTC  DEEP PAIN CARE HOT
camphor, capsicum, menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45156-5605
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Camphor (Natural) (Camphor (Natural)) Camphor (Natural)4 g  in 1000 g
Capsicum (Capsicum) Capsicum38 g  in 1000 g
Menthol (Menthol) Menthol17 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Dimethyl Sulfone 
Ginger 
Soybean Oil 
Arctium Lappa Root 
Juniper Berry Oil 
Cat's Claw 
Wormwood 
Black Pepper 
Arnica Montana Flower 
Alpha-Tocopherol 
Xanthan Gum 
Niacinamide 
Phenoxyethanol 
Iodopropynyl Butylcarbamate 
Corymbia Citriodora Leaf Oil 
Packaging
#Item CodePackage Description
1NDC:45156-5605-21 TUBE (TUBE) in 1 BOX
1NDC:45156-5605-131 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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