Label: DENTAL C-PATCH- menthol, camphor patch
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Contains inactivated NDC Code(s)
NDC Code(s): 70236-104-01, 70236-104-02 - Packager: NeoBiotech Global Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 February 10, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
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Warnings
For external use only
When using this product
Use only as directed.
- Do not bandage tightly or use with heating pad
- Avoid contact with eyes and mucus membranes
- Do not appy wounds or broken skin
- Do not apply to large areas of the body
- In case of deep or puncture wounds, animal bites or serious burns, consult a doctor
Stop use and ask a doctor if
- condition worsen
- irritation develops
- symptoms persist for more than 7 days or recurs within 1 day of discontinuation
- do not use for more than 7 days
If pregnant or breast-feeding, ask a health professional before use
Keep out of reach of children. If swallowd, contact a Poison Control Center or get medical help immediatel
- Directions
- Inactive ingredients
- Keep out of reach of children
- Dental C-Patch
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INGREDIENTS AND APPEARANCE
DENTAL C-PATCH
menthol, camphor patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70236-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.07 g in 14 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.35 g in 14 g Inactive Ingredients Ingredient Name Strength EDETIC ACID (UNII: 9G34HU7RV0) ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) SORBITOL (UNII: 506T60A25R) TARTARIC ACID (UNII: W4888I119H) GLYCERIN (UNII: PDC6A3C0OX) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) EUCALYPTUS OIL (UNII: 2R04ONI662) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70236-104-02 5 in 1 POUCH 02/10/2018 1 NDC:70236-104-01 14 g in 1 PATCH; 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 02/10/2018 Labeler - NeoBiotech Global Corporation (080020820) Registrant - NeoBiotech Global Corporation (080020820) Establishment Name Address ID/FEI Business Operations NeoBiotech Global Corporation 080020820 manufacture(70236-104)
