NDC | 50804-077-01 |
Set ID | ed9297f7-7f01-4ef1-81af-d9c90650672b |
Category | HUMAN OTC DRUG LABEL |
Packager | GOOD SENSE |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
- Warnings
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
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INGREDIENTS AND APPEARANCE
GOOD SENSE ULTRA STRENGTH MUSCLE RUB
camphor, (-)-, menthol, unspecified form, and methyl salicylate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-077 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275) CAMPHOR, (-)- 40 mg in 1 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 100 mg in 1 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 300 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50804-077-01 1 in 1 CARTON 12/19/2018 1 113 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 12/19/2018 Labeler - GOOD SENSE (076059836) Establishment Name Address ID/FEI Business Operations NATUREPLEX LLC 062808196 MANUFACTURE(50804-077)