NDC | 51681-0041-1, 51681-0041-2, 51681-0041-3 |
Set ID | c0d347eb-eab0-4132-874b-0d162b3fe12c |
Category | HUMAN OTC DRUG LABEL |
Packager | JELMA PHILIPPINES INC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- 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 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 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
-
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