Label: HONG HOA PAIN RELIEVING- camphor, capsaicin, and methyl salicylate oil
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Contains inactivated NDC Code(s)
NDC Code(s): 55614-640-02 - Packager: MADISON ONE ACME INC
- 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 May 15, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- 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
■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
■ you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)
■ 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 - ADVERSE REACTIONS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HONG HOA PAIN RELIEVING
camphor, capsaicin, and methyl salicylate oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55614-640 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 g in 100 mL CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.025 g in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 60 g in 100 mL Inactive Ingredients Ingredient Name Strength CINNAMON LEAF OIL (UNII: S92U8SQ71V) CINNAMON OIL (UNII: E5GY4I6YCZ) CITRONELLA OIL (UNII: QYO8Q067D0) DRAGON'S BLOOD (UNII: M3YJ2C28IC) LIGHT MINERAL OIL (UNII: N6K5787QVP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55614-640-02 1 in 1 BOX 05/15/2020 1 50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/15/2020 Labeler - MADISON ONE ACME INC (096196758) Establishment Name Address ID/FEI Business Operations Zhejiang Dingtai Pharmaceutical Co., Ltd 420598724 manufacture(55614-640)