Label: HERBALGY- camphor menthol methyl salicylate oil
-
Contains inactivated NDC Code(s)
NDC Code(s): 66897-003-50 - Packager: Wicsun Trading
- 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 February 27, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
-
STOP USE
Stop use and ask a doctor if:
- Condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.
- Excessive irritation of the skin develops.
- When using this product for arthritis: Pain persists for more than 10 days, redness is present or in conditions affecting children under 12 years of age
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HERBALGY
camphor menthol methyl salicylate oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66897-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 10 mL in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 16 mL in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 31.5 mL in 100 mL Inactive Ingredients Ingredient Name Strength EUCALYPTUS OIL (UNII: 2R04ONI662) FRANKINCENSE (UNII: R9XLF1R1WM) MYRRH (UNII: JC71GJ1F3L) CORYDALIS YANHUSUO TUBER (UNII: 0TUP42692Z) DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66897-003-50 50 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/15/2012 Labeler - Wicsun Trading (960476174) Establishment Name Address ID/FEI Business Operations Herbalgy Pharmaceutical Limited 667293554 manufacture