Label: WONG TO YICK EXTERNAL ANALGESIC- camphor menthol methyl salicylate oil
- NDC Code(s): 57597-043-01
- Packager: Wong To Yick Wood Lock Ointment 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.
Updated December 12, 2017
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- Active Ingredients
- When using this product
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
- nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
when using for pain of arthritis
- 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
- adults and children above 3 years of age: apply 3 to 4 drops of medicated oil to the affected area 1 to 2 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massaged as shown in the illustrations.
- children under 3 years of age: consult your physician.
- refer to the above warnings; use otherwise than as directed may be dangerous.
- Other Information
- Inactive Ingredients
- Package Label
INGREDIENTS AND APPEARANCE
WONG TO YICK EXTERNAL ANALGESIC
camphor menthol methyl salicylate oil
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57597-043 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 1 mg in 10 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.6 mg in 10 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 5 mg in 10 mL Inactive Ingredients Ingredient Name Strength LAVENDER OIL (UNII: ZBP1YXW0H8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57597-043-01 50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 11/15/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/15/2011 Labeler - Wong To Yick Wood Lock Ointment Ltd (664995651) Establishment Name Address ID/FEI Business Operations Wong To Yick Wood Lock Ointment Ltd 664995651 manufacture(57597-043)