Label: BAROX BODY CARE MASSAGE- menthol gel
- NDC Code(s): 55692-100-01
- Packager: Dr.JangLab Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- ACTIVE INGREDIENT
Active ingredient: Menthol 2%Close
- INACTIVE INGREDIENT
Water, Alcohol, Propylene Glycol, Germanium Dioxide, Allantoin, Carbomer, Triethanolamine, PEG-60 Hydrogenated Castor Oil, Disodium EDTA, Methylparaben
Purpose: Topical AnalgesicClose
Warnings: For external use onlyClose
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children:Close
Keep out of reach of children to avoid accidental ingestion.
If swallowed, get medical help or contact a Poison Control Center immediately.
Temporarily relieves the minor pains of muscles and joints associated with:
simple backache and arthritis
- DOSAGE AND ADMINISTRATION
Dosage and administration:Close
adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 12 years of age: ask a doctor
- PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
BAROX BODY CARE MASSAGE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55692-100 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (MENTHOL) Menthol 2.4 mg in 120 mL Inactive Ingredients Ingredient Name Strength WATER ALCOHOL PROPYLENE GLYCOL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55692-100-01 120 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/01/2012 Labeler - Dr.JangLab Inc. (688380051) Registrant - Dr.JangLab Inc. (688380051) Establishment Name Address ID/FEI Business Operations Dr.JangLab Inc. 688380051 manufacture(55692-100)