Label: WHITE FLOWER ANALGESIC BALM- camphor, menthol, and methyl salicylate oil
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Contains inactivated NDC Code(s)
NDC Code(s): 51681-0001-1, 51681-0001-2, 51681-0001-3, 51681-0001-4 - Packager: JELMA PHILIPPINES INC
- Category: HUMAN OTC DRUG LABEL
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 October 15, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DO NOT USE
- WARNINGS
- 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 age
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
WHITE FLOWER ANALGESIC BALM
camphor, menthol, and methyl salicylate oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51681-0001 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 6 g in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 14.6 g in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 40 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:51681-0001-1 20 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 06/14/2010 2 NDC:51681-0001-2 10 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 06/14/2010 3 NDC:51681-0001-4 2.5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 06/14/2010 4 NDC:51681-0001-3 5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 06/14/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/14/2010 Labeler - JELMA PHILIPPINES INC (721085447)