Label: WHITE FLOWER ANALGESIC BALM FLORAL SCENTED- camphor, menthol and methyl salicylate oil
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Contains inactivated NDC Code(s)
NDC Code(s): 51681-0011-1, 51681-0011-2 - Packager: JELMA PHILIPPINES 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 July 30, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- DO NOT USE
- 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
- when using for pain of arthritis:
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- pain persists for more than 10 days
- redness is present
- in conditions affecting children under 12 years of ag
- KEEP OUT OF REACH OF CHILDREN
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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
- PRINCIPAL DISPLAY PANEL
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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:51681-0011 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 13.0 g in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 35.8 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51681-0011-1 10 mL in 1 BOTTLE, GLASS 2 NDC:51681-0011-2 5 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 07/20/2010 Labeler - JELMA PHILIPPINES INC (721085447)