DR. OH BALM - camphor, capsaicin and menthol cream 
Ecometics, Inc.

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

Camphor 3.5% .. Topical Analgesic
Menthol 1% .. Topical Analgesic
Capsaicin 0.015% .. Topical Analgesic

image of drug facts panel

image of drug facts panel

Benzyl Benzoate and Cymbopogon Nardus [ Citronella ] Oil and Citronellal and Citronellol
. . . and Dodecanal and Geraniol and Eucalyptus Globulus Leaf Oil and Thymol and Phenoxybenzene
Castor Oil
Cetearyl Isononanoate and Ceteareth - 20 and Cetearyl Alcohol and Glyceryl Stearate and Glycerin
. . . and Ceteareth - 2 and Cetyl Palmitate
Hydroxyethyl Acrylate / Sodium Acryloyldimethyl Taurate Copolymer and Squalane [ plant origin ] and Polysorbate 60
Propylene Glycol and Diazolidinyl Urea and Mehtylparaben and Propylparaben
Water

NDC 17452-430-01
Dr. OH BALM (TM)
Excellent for muscle and tendon pain
made with essential oils
Patents pending
Information: www.drohbalm.com
NET WT. 57g (2oz)

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image of PDP

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image of tube

For external use only
Do not use on broken, damaged or irritated skin.
Avoid contact with eyes or mucous membranes.
Do not bandage.

Stop use and consult a physician,
if skin redness or excessive irritation develops or if pain last more than 7 days.
For best results, refrain from strenuous activity while treating affected.

Topical analgesic. Provides temporary relief of minor aches and pains.

Apply generously and gently massage until Dr. OH BALM disappears.
Apply no more than 3 times daily.

Other Information: Store in a cool, dry location away from sunlight.
Distributed by
Dr. OH PATCH Inc.
P.O. BOX 1646
LORTON, VA 22079
www.drohbalm.com
Made in U.S.A.

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image of carton

Keep out of reach of children
Do not use on children under 12 years of age.
If balm is swallowed, get medical help or contact a poison control center immediately.

Apply generously and gently massage until Dr. OH BALM disappears.
Apply no more than 3 times daily.

DR. OH BALM 
camphor, capsaicin and menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17452-430
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.015 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
BENZYL BENZOATE (UNII: N863NB338G)  
CITRONELLA OIL (UNII: QYO8Q067D0)  
CITRONELLAL (UNII: QB99VZZ7GZ)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
LAURYL ALDEHYDE (UNII: C42O120SEF)  
GERANIOL (UNII: L837108USY)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
THYMOL (UNII: 3J50XA376E)  
CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
SQUALANE (UNII: GW89575KF9)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BENZOPHENONE (UNII: 701M4TTV9O)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17452-430-0157 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/23/2012
Labeler - Ecometics, Inc. (064843923)

Revised: 4/2012
Document Id: bf08608c-f821-4594-8d03-de3f59c5521c
Set id: c675b139-3fd6-4b13-b87d-fc171f31888b
Version: 1
Effective Time: 20120426
 
Ecometics, Inc.