Label: THERAPEUTIC RELIEF PREFERRED PLUS PHARMACY- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 61715-021-08 - Packager: Kinray Inc.
- 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.
Drug Label Information
Updated June 20, 2013
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only. When using this product: avoid contact with the eyes, do not bandage tightly, do not apply to wounds or damaged skin, and do not use with heating pads of other heating devices. Stop use and ask doctor if: condition gets worse, symptoms last more than 7 days, or symptoms clear up and occur again in a few days.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
THERAPEUTIC RELIEF PREFERRED PLUS PHARMACY
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 2 g in 100 g Inactive Ingredients Ingredient Name Strength Ammonia (UNII: 5138Q19F1X) Carbomer 934 (UNII: Z135WT9208) Cupric Sulfate (UNII: LRX7AJ16DT) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Isopropyl Alcohol (UNII: ND2M416302) Magnesium Sulfate (UNII: DE08037SAB) Sodium Hydroxide (UNII: 55X04QC32I) Thymol (UNII: 3J50XA376E) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61715-021-08 227 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/15/2013 Labeler - Kinray Inc. (012574513)