Label: FLEX24 PERFORMANCE- camphor menthol patch
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Contains inactivated NDC Code(s)
NDC Code(s): 54641-007-01 - Packager: Larasan Pharmaceutical Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
Drug Label Information
Updated January 21, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only.
Stop Use and Ask a Doctor
if condition worsens or if there is redness or irritation in the applied area or if symptoms persist for more than 7 days or clear up and occur again within a few days
- Directions
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Inactive Ingredients
Angelica Dahurica, Cape Jasmine Fruit, Chinese Angelica, Cotton, Eucalyptus Oil, Ethyl Alcohol, Forsythia Seed Pod,
Fortune’s Drynaria Rhizome, Frankincense, Kusnezoff Monkshood root, Lavender Oil, Manchurian Wild Ginger, Myrrh,
Paper roll, Peppermint Oil, Pinellia Tuber, Red Peony Root, Rehmannia Root (raw), Rhubarb, Safflower, Slenderstyle
Acanthopanax Bark, Tangerine Peel, Tree Peony Bark, Turmeric, Weeping Wintergreen Oil, White Peony Root,
Zanthoxylum Nitidum, Zedoary. - Other Information
- Questions/Comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FLEX24 PERFORMANCE
camphor menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54641-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 3 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.52 g in 100 g Inactive Ingredients Ingredient Name Strength ANGELICA DAHURICA ROOT (UNII: 1V63N2S972) GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549) ANGELICA SINENSIS ROOT (UNII: B66F4574UG) COTTON FIBER (UNII: 70LDW53ROO) EUCALYPTUS OIL (UNII: 2R04ONI662) ALCOHOL (UNII: 3K9958V90M) FORSYTHIA SUSPENSA FRUIT (UNII: P4793M1ES5) DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q) FRANKINCENSE (UNII: R9XLF1R1WM) ACONITUM KUSNEZOFFII ROOT (UNII: 3L29I4K8KX) LAVENDER OIL (UNII: ZBP1YXW0H8) GINGER (UNII: C5529G5JPQ) MYRRH (UNII: JC71GJ1F3L) PEPPERMINT OIL (UNII: AV092KU4JH) PINELLIA TERNATA ROOT (UNII: G9AET085M5) PAEONIA OBOVATA ROOT (UNII: 7NPF74465O) REHMANNIA ELATA ROOT (UNII: 4PTH680I21) RHUBARB (UNII: G280W4MW6E) SAFFLOWER (UNII: 4VBL71TY4Y) ELEUTHEROCOCCUS NODIFLORUS ROOT BARK (UNII: W7PRK433YB) TANGERINE PEEL (UNII: JU3D414057) PAEONIA SUFFRUTICOSA ROOT BARK (UNII: BUG255FE7X) TURMERIC (UNII: 856YO1Z64F) METHYL SALICYLATE (UNII: LAV5U5022Y) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54641-007-01 1 in 1 PACKAGE 01/16/2017 1 1.56 g in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/16/2017 Labeler - Larasan Pharmaceutical Corporation (078350375) Establishment Name Address ID/FEI Business Operations Dong-e E-jiao E-hua Medical Equipment Co Ltd 527813247 manufacture(54641-007)