Label: NEW TEROCIN- methyl salicylate, capsaicin, and menthol lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68258-3981-4 - Packager: Dispensing Solutions, Inc.
- This is a repackaged label.
- Source NDC Code(s): 50488-1129
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 12, 2013
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
- Only for external use.
- Do not use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.
- Consult your physician: if pain is persistent or worsens or if using any other topical pain products.
- 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), Cetyl Alcohol, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate,
Propylene Glycol, Dimethyl Sulfone, Lavandula Angustifolia (Lavendar) Oil,
Lidocaine, 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 NDC 68258-3981-04
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INGREDIENTS AND APPEARANCE
NEW TEROCIN
methyl salicylate, capsaicin, and menthol lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68258-3981(NDC:50488-1129) 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 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) LIDOCAINE (UNII: 98PI200987) LAVENDER OIL (UNII: ZBP1YXW0H8) 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:68258-3981-4 120 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/13/2013 Labeler - Dispensing Solutions, Inc. (066070785) Registrant - PSS World Medical, Inc. (101822682) Establishment Name Address ID/FEI Business Operations Dispensing Solutions, Inc. 066070785 relabel(68258-3981) , repack(68258-3981)
Bottle Label