Label: HYSAN HUA TUO HUO LU (methyl salicylate, camphor- synthetic oil
- NDC Code(s): 63255-123-01, 63255-123-02
- Packager: HYSAN PHARMACEUTICAL CO LTD
- 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 18, 2021
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYSAN HUA TUO HUO LU
methyl salicylate, camphor (synthetic) oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63255-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 37 g in 100 mL CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 10 g in 100 mL Inactive Ingredients Ingredient Name Strength MENTHOL (UNII: L7T10EIP3A) TURPENTINE OIL (UNII: C5H0QJ6V7F) EUCALYPTUS OIL (UNII: 2R04ONI662) LAVENDER OIL (UNII: ZBP1YXW0H8) TOLU BALSAM (UNII: TD2LE91MBE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63255-123-01 50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 02/18/2021 2 NDC:63255-123-02 3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 02/18/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/18/2021 Labeler - HYSAN PHARMACEUTICAL CO LTD (666427133) Establishment Name Address ID/FEI Business Operations HYSAN PHARMACEUTICAL CO LTD 666427133 manufacture(63255-123)