NDC | 51681-0001-1, 51681-0001-2, 51681-0001-3, 51681-0001-4 |
Set ID | b047dade-a69e-40f5-b157-882bf2346796 |
Category | HUMAN OTC DRUG LABEL |
Packager | JELMA PHILIPPINES INC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DO NOT USE
- WARNINGS
- 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
- 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)