Label: WHITE FLOWER STRAIN RELIEF- camphor, menthol and methyl salicylate oil
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Contains inactivated NDC Code(s)
NDC Code(s): 51681-0041-1, 51681-0041-2, 51681-0041-3 - 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 February 20, 2012
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- 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 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
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DOSAGE & ADMINISTRATION
Directions
■ adults and children 3 years of age and older: apply on the affected area not more than 3 to 4 times daily.
After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massage gently.
■ children under 3 years of age: do not use, consult your 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 STRAIN RELIEF
camphor, menthol and methyl salicylate oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51681-0041 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 MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 15 g in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 50 g in 100 mL Inactive Ingredients Ingredient Name Strength BETA CAROTENE (UNII: 01YAE03M7J) CHINESE CINNAMON OIL (UNII: A4WO0626T5) D&C GREEN NO. 6 (UNII: 4QP5U84YF7) D&C RED NO. 17 (UNII: ND733RX3JN) EUCALYPTUS OIL (UNII: 2R04ONI662) LAVENDER OIL (UNII: ZBP1YXW0H8) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51681-0041-1 50 mL in 1 BOTTLE, GLASS 2 NDC:51681-0041-2 25 mL in 1 BOTTLE, GLASS 3 NDC:51681-0041-3 3 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 02/20/2012 Labeler - JELMA PHILIPPINES INC (721085447) Establishment Name Address ID/FEI Business Operations JELMA PHILIPPINES INC 721085447 repack Establishment Name Address ID/FEI Business Operations HOE HIN PAK FAH YEOW MANUFACTORY LTD 686359001 manufacture