Label: DR. OH BALM- camphor, capsaicin and menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 17452-430-01 - Packager: Ecometics, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated April 26, 2012
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
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
- PRINCIPAL DISPLAY PANEL
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WARNINGS
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.
- PURPOSE
- INDICATIONS & USAGE
- INFORMATION FOR PATIENTS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INGREDIENTS AND APPEARANCE
DR. OH BALM
camphor, capsaicin and menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17452-430 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 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) CAPSAICIN 0.015 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:17452-430-01 57 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/23/2012 Labeler - Ecometics, Inc. (064843923)
