Label: WHITE FLOWER ANALGESIC BALM FLORAL SCENTED- camphor, menthol and methyl salicylate oil
- NDC Code(s): 48256-0011-1, 48256-0011-2
- Packager: HOE HIN PAK FAH YEOW MANUFACTORY LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 2, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- DO NOT USE
- WHEN USING
-
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
- 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
-
DOSAGE & ADMINISTRATION
Directions
- adults and children 3 years of age and older: apply one to two drops to the affected area not more than 3 to 4 times daily. Massage gently.
- children under 3 years of age and pregnant women: do not use, consult a physician
- refer to the above warnings; use otherwise than as directed may be dangerous
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- INDICATIONS & USAGE
- WARNINGS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
WHITE FLOWER ANALGESIC BALM FLORAL SCENTED
camphor, menthol and methyl salicylate oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48256-0011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 5.4 g in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 13 g in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 35.8 g in 100 mL Inactive Ingredients Ingredient Name Strength EUCALYPTUS OIL (UNII: 2R04ONI662) LAVENDER OIL (UNII: ZBP1YXW0H8) PEPPERMINT OIL (UNII: AV092KU4JH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48256-0011-1 10 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/30/2010 2 NDC:48256-0011-2 5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 07/30/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 07/30/2010 Labeler - HOE HIN PAK FAH YEOW MANUFACTORY LTD (686359001) Establishment Name Address ID/FEI Business Operations HOE HIN PAK FAH YEOW MFY LTD 686212961 manufacture(48256-0011)
