Label: FLEX24 PERFORMANCE- camphor, menthol patch
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Contains inactivated NDC Code(s)
NDC Code(s): 54641-006-01 - 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 December 8, 2019
If you are a consumer or patient please visit this version.
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- 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
- Keep out of reach of children
- Directions
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Inactive Ingredients
Angelica Dahurica Root, Atractylodes Lancea Root, Borneol, Chinese Angelica, Chondroitin Sulfate, Ginger, Kaempferia Galanga Root, Kusnezoff Monkshood Root (raw), Lemon, Ligusticum Sinense/Subsp. Chuanxiong Root, Mineral Oil, Musk, Petrolatum, Radix Aconiti, Rosin, Silicone, Star Anise, Wintergreen Oil, Zinc Oxide
- Other Information
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- SPL UNCLASSIFIED SECTION
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- 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:54641-006 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) ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O) BORNEOL (UNII: M89NIB437X) ANGELICA SINENSIS ROOT (UNII: B66F4574UG) CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z) GINGER (UNII: C5529G5JPQ) KAEMPFERIA GALANGA ROOT (UNII: 7B7U9D12AI) ACONITUM KUSNEZOFFII ROOT (UNII: 3L29I4K8KX) Lemon (UNII: 24RS0A988O) LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97) MINERAL OIL (UNII: T5L8T28FGP) MOSCHUS BEREZOVSKII MUSK SAC RESIN (UNII: Z70MFY52S4) PETROLATUM (UNII: 4T6H12BN9U) ACONITUM NAPELLUS ROOT (UNII: KPD2N7348X) ROSIN (UNII: 88S87KL877) STAR ANISE (UNII: XKC1657P78) METHYL SALICYLATE (UNII: LAV5U5022Y) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54641-006-01 7 in 1 PACKAGE 04/08/2014 1 1.56 g in 1 PATCH; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/08/2014 Labeler - Larasan Pharmaceutical Corporation (078350375) Establishment Name Address ID/FEI Business Operations Dong E E Hua Medical Technology Co Ltd 527813247 manufacture(54641-006)