INFLAMMATION OTC DEEP PAIN CARE COLD- camphor, menthol lotion 
Skin Deep

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.

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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

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 Box

INFLAMMATION OTC  DEEP PAIN CARE COLD
camphor, menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45156-5610
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Camphor (Natural) (UNII: N20HL7Q941) (Camphor (Natural) - UNII:N20HL7Q941) Camphor (Natural)18 g  in 600 g
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol16 g  in 600 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
Black Pepper Oil (UNII: U17J84S19Z)  
Soybean Oil (UNII: 241ATL177A)  
Arctium Lappa Root (UNII: 597E9BI3Z3)  
Peppermint (UNII: V95R5KMY2B)  
Wormwood (UNII: F84709P2XV)  
Cat's Claw (UNII: 9060PRM18Q)  
Ginger Oil (UNII: SAS9Z1SVUK)  
Arnica Montana (UNII: O80TY208ZW)  
Ginger (UNII: C5529G5JPQ)  
Trideceth-6 (UNII: 3T5PCR2H0C)  
Alpha-Tocopherol (UNII: H4N855PNZ1)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45156-5610-21 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/FEIBusiness Operations
Skin Deep833276566manufacture

Revised: 8/2011
Document Id: a1c737d4-eec3-4bda-b406-54aab5b66e3f
Set id: 234ad5c5-31bb-47e7-a29b-bcd079de2aeb
Version: 1
Effective Time: 20110816
 
Skin Deep