Label: TONG LUO QU TONG GAO- camphor and menthol poultice
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Contains inactivated NDC Code(s)
NDC Code(s): 42217-100-01 - Packager: HENAN LINGRUI PHARMACEUTICAL CO LTD
- 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 2, 2010
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- DO NOT USE
- ASK DOCTOR/PHARMACIST
- WHEN USING
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STOP USE
Stop use and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
- excessive irritation of the skin develops
- when using for pain of arthritis:
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- pain persists for more than 10 days
- redness is present
- in conditions affecting children under 12 years of age
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- adults and children 12 years of age and older: Apply one or two plasters to affected area once a day. Remove after 12 hours.
- children 2 to 12 years of age and adults with compromised health: Use only under the guidance of a doctor
- children under 2 years of age: Do not use, consult a doctor
Refer to the above warnings; use otherwise than as directed may be dangerous.
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients Chinese rhubarb rhizome and root, cinnamon bark, clove,
dimethyl sulfoxide, dong-quai root, ginger rhizome, greater galangal rhizome, green
peppercorns, lanolin, long pepper (Piper longum L.) fruit, paraffin, petrolatum, rosin,
safflower flowers, Sichuan lovage rhizome, Sichuan pepper [Zanthoxylum piperitum (L.)
DC.] peel, and zinc oxide, on a rubberized fabric support with a paper backing.
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TONG LUO QU TONG GAO
camphor and menthol poulticeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42217-100 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 5 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3.4 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42217-100-01 4 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/02/2010 Labeler - HENAN LINGRUI PHARMACEUTICAL CO LTD (530021062) Establishment Name Address ID/FEI Business Operations HENAN LINGRUI PHARMACEUTICAL CO LTD 530021062 manufacture