Label: PAIN RELIEVING ANALGESIC- menthol gel
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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.
Updated January 20, 2012
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- Active Ingredients
Use only as directed.
For external use only. If swallowed contact a physician or poison control center immediately. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Make sure skin is clean and free of any creams ointments, sprays or liniments. Do not cover with bandage.
Do not use
with heating pads or heating devices.
Discontinue use and consult a physician if skin irritation develops, condition recurs, worsens or symptoms persist for more that 7 days. Consult your doctor before use if you are pregnant or nursing. Do not use, pour, spill or store near heat or open flame. Store in a cool, dry place. Keep lid tightly closed.
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
PAIN RELIEVING ANALGESIC
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52920-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4.54 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) CARBOMER 934 (UNII: Z135WT9208) SODIUM HYDROXIDE (UNII: 55X04QC32I) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) NONOXYNOL-10 (UNII: K7O76887AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52920-123-03 227 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 09/21/2009 Labeler - Singhfam Corporation (019499958) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd. 916837425 MANUFACTURE(52920-123)