Label: BAROX- menthol gel
- Category: HUMAN OTC DRUG LABEL
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.
Updated August 15, 2012
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- Active ingredient
- Inactive ingredient
- Keep out of reach of children
- Dosage and administration
Ask a doctor before use if you have redness over the affected area.
Do not use: on wounds or damaged skin
Stop use and ask a doctor if excessive skin irritation occurs.
Store in a cool dry place with lid closed tightly
- PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52227-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3 g in 120 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 82.2 g in 120 mL ALCOHOL (UNII: 3K9958V90M) 18 g in 120 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 4.8 g in 120 mL GERMANIUM DIOXIDE (UNII: 5O6CM4W76A) 0.96 g in 120 mL TROLAMINE (UNII: 9O3K93S3TK) 0.6 g in 120 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52227-100-01 120 mL in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/01/2012 Labeler - KTAIGA CO., LTD. (557819324) Registrant - KTAIGA CO., LTD. (557819324) Establishment Name Address ID/FEI Business Operations KTAIGA CO., LTD. 557819324 manufacture(52227-100)