Label: CANKER COMPLETE CANKER SORE RELIEF- menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 44717-890-01, 44717-890-02 - Packager: Wasatch Product Development
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 May 22, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredient Purpose
Menthol 0.5% Oral Pain Reliever
Stop use and ask a dentist or physician if
- Sore mouth symptoms do not improve in 7 days
- Irritation, pain or redness worsens
- Swelling, rash or fever develops
Directions
Adults and children 2 years and older Gently dab medication on the site of irritation with a cotton swab or fingertip
Apply to the affected area up to 4 times a day, or as directed by a dentist or physician
Children under 12 years Adult supervision should be given in the use of this product
Children under 2 years Consult dentist or physician
Inactive ingredients:
Calcium/Sodium PVM/MA Copolymer, TX-Factor 5 tm (propietary polypeptide lipid blend), Cellulose Gum, Mineral Oil, Petrolatum, Lecithin, Chlorella Vulgaris Extract, Hydrolyzed Lupine Protein, Silica, C12-15 Alkyl Benzoate, Tribehenin, Ceramide 2, PEG-10 Rapeseed Sterol, Tetrasodium EDTA, Flavor, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Caprylyl Glycol, Stearyl Glycyrrhetinate, Sucralose, DC Red Lake 27
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CANKER COMPLETE CANKER SORE RELIEF
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44717-890 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) CHLORELLA VULGARIS (UNII: RYQ4R60M02) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) TRIBEHENIN (UNII: 8OC9U7TQZ0) CERAMIDE 2 (UNII: C04977SRJ5) PEG-10 RAPESEED STEROL (UNII: 258O76T85M) EDETATE SODIUM (UNII: MP1J8420LU) TEA TREE OIL (UNII: VIF565UC2G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44717-890-02 1 in 1 BOX 10/12/2010 1 NDC:44717-890-01 6 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 final part341 10/12/2010 Labeler - Wasatch Product Development (962452533) Registrant - Wasatch Product Development (962452533) Establishment Name Address ID/FEI Business Operations Wasatch Product Development 962452533 manufacture(44717-890)
