![TEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [PREFERRED PHARMACEUTICALS, INC.]](https://medic.hrt.org//dailymed/images/1402d6fc-73e9-4702-a2e3-71485d37122f/1402d6fc-73e9-4702-a2e3-71485d37122f-01.jpg)
| NDC | 68788-9496-1 |
| Set ID | 1402d6fc-73e9-4702-a2e3-71485d37122f |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Preferred Pharmaceuticals, Inc. |
| Generic Name | |
| Product Class | Amide Local Anesthetic, Antiarrhythmic |
| Product Number | |
| Application Number | PART348 |
- Active ingredient
- Purpose
- Uses
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Warnings
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- Only for external use.
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- Do not use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.
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- Consult your physician: if pain is persistent or worsens or if using any other topical pain products.
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- Call poison control if swallowed. If contact with the eyes occurs, rinse eyes thoroughly with cold water.
- Keep out of reach of children.
- Directions
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Inactive ingredients
Water (Aqua), Propylene Glycol, Cetyl Alcohol, Stearic Acid, Glyceryl Stearate,
PEG-100 Stearate, Dimethyl Sulfone, Aloe Barbadensis Leaf Extract, Borago
Officinalis Seed Oil, Boswellia Serrata Extract, Xanthan Gum, Triethanolamine,
Methylparaben, Propylparaben, DMDM Hydantoin, Iodopropynyl Butylcarbamate.
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
TEROCIN
methyl salicylate, capsaicin, menthol and lidocaine hydrochloride lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-9496(NDC:50488-1231) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 25 g in 100 mL CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.025 g in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g in 100 mL LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CETYL ALCOHOL (UNII: 936JST6JCN) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) ALOE VERA LEAF (UNII: ZY81Z83H0X) BORAGE OIL (UNII: F8XAG1755S) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) XANTHAN GUM (UNII: TTV12P4NEE) TROLAMINE (UNII: 9O3K93S3TK) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) DMDM HYDANTOIN (UNII: BYR0546TOW) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-9496-1 120 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/20/2014 Labeler - Preferred Pharmaceuticals, Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals, Inc. 791119022 RELABEL(68788-9496)
