NDC | 76437-609-16 |
Set ID | 99dcdb92-58f3-4f10-8f4d-d7a1b927e6ce |
Category | HUMAN OTC DRUG LABEL |
Packager | Reed Therapeutics |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART356 |
- Drug Facts
- Uses
- Warnings
- Keep out of reach of children
- When using this product
- Stop use and ask a doctor if
- Directions
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
REED THERAPEUTICS PAIN RELIEVING THERAPY
methyl salicylate, menthol usp, camphor gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76437-609 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 12.5 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4 g in 100 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.2 g in 100 g Inactive Ingredients Ingredient Name Strength CARBOMER 940 (UNII: 4Q93RCW27E) DMDM HYDANTOIN (UNII: BYR0546TOW) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ILEX PARAGUARIENSIS WHOLE (UNII: QJB02841ZY) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) TEA TREE OIL (UNII: VIF565UC2G) THYME OIL (UNII: 2UK410MY6B) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76437-609-16 454 g in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 03/23/2013 Labeler - Reed Therapeutics (032505137) Registrant - Geritrex (112796248) Establishment Name Address ID/FEI Business Operations Geritrex 112796248 manufacture(76437-609)