Label: FLEX24 PERFORMANCE PEN- camphor liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 54641-004-02 - 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- 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
Aconitum kusnezoffii root, Angelica dahurica root, Angelica sinesis root, Asarum heterotropoides var. mandshuricum root, Drynaria fortunei root, Eleutherococcus nodiflorus root bark, Ethyl alcohol, Eucalyptus oil, Frosythia suspensa fruit, Frankincense, Gardenia jasminoides fruit, Lavender oil, Lemon, Myrrh, Paeonia suffruticosa root bark, Peppermint oil, Pinellia ternata root, Red paeonia lactiflora root, Rhemannia glutinosa root (raw), Rhubarb, Safflower, Tangerine peel, Turmeric, White paeonia lactiflora root, Wintergreen oil, Zanthoxylum nitidum root, Zeodary
- Other Information
- Questions/Comments?
- Distributed By:
- Flex24™ Performance Pen
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INGREDIENTS AND APPEARANCE
FLEX24 PERFORMANCE PEN
camphor liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54641-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 7.79 g in 100 mL Inactive Ingredients Ingredient Name Strength ANGELICA DAHURICA ROOT (UNII: 1V63N2S972) ACONITUM KUSNEZOFFII ROOT (UNII: 3L29I4K8KX) ANGELICA SINENSIS ROOT (UNII: B66F4574UG) ASARUM HETEROTROPOIDES VAR. MANDSHURICUM ROOT (UNII: HK49KSK8L3) DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q) ELEUTHEROCOCCUS NODIFLORUS ROOT BARK (UNII: W7PRK433YB) ALCOHOL (UNII: 3K9958V90M) EUCALYPTUS OIL (UNII: 2R04ONI662) FORSYTHIA SUSPENSA FRUIT (UNII: P4793M1ES5) FRANKINCENSE (UNII: R9XLF1R1WM) GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549) LAVENDER OIL (UNII: ZBP1YXW0H8) LEMON (UNII: 24RS0A988O) MYRRH (UNII: JC71GJ1F3L) PAEONIA SUFFRUTICOSA ROOT BARK (UNII: BUG255FE7X) PEPPERMINT OIL (UNII: AV092KU4JH) PINELLIA TERNATA ROOT (UNII: G9AET085M5) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ) RHUBARB (UNII: G280W4MW6E) SAFFLOWER (UNII: 4VBL71TY4Y) TANGERINE PEEL (UNII: JU3D414057) TURMERIC (UNII: 856YO1Z64F) METHYL SALICYLATE (UNII: LAV5U5022Y) ZANTHOXYLUM NITIDUM ROOT (UNII: L2CQZ81759) ZEDOARY (UNII: 123C43G128) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54641-004-02 10 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 04/08/2014 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(54641-004)