DR. OH BALM- camphor, capsaicin and menthol cream

Dr. OH BALM by

Drug Labeling and Warnings

Dr. OH BALM by is a Otc medication manufactured, distributed, or labeled by Ecometics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

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)

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

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

INDICATIONS & USAGE

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

INFORMATION FOR PATIENTS

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.

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

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

INGREDIENTS AND APPEARANCE

DR. OH BALM 
camphor, capsaicin and menthol cream

Product 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)