Label: BENEPATCH- lidocaine hydrochloride, menthol patch
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Contains inactivated NDC Code(s)
NDC Code(s): 69418-002-01 - Packager: Meds Direct Rx, Inc.
- 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 November 18, 2015
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS:
- PURPOSE
- USES:
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WARNINGS:
- For external use only.
- Avoid contact with eyes.
- Do not apply on open wounds or damaged skin.
- If symptoms persist for more than seven days, discontinue use and consult physician.
- Do not bandage tightly.
- If pregnant or breast-feeding, contact physician prior to use.
- Do not use in large quantities, particularly over raw surfaces or blistered areas.
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DIRECTIONS:
- Clean and dry affected area.
- Remove patch from backing and apply to affected area.
- Use only one patch at a time, and maximum of four patches/day.
- Leave patch on affected area for up to 8 hours.
- Do not use patches for longer than 5 consecutive days.
- Children under 12 should consult physician prior to use.
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OTHER INGREDIENTS:
Aloe Barbadensis Leaf (Aloe Vera Juice) Gel, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Camellia Sinensis Leaf (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbate-80, Sodium Lauryl Sulfate, Triethanolamine, FD&C Blue #1, FD&C Yellow #5.
- Package Labeling for BenePatch, 15 Count (69418-002-01)
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INGREDIENTS AND APPEARANCE
BENEPATCH
lidocaine hydrochloride, menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69418-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g in 100 g Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) GLYCERIN (UNII: PDC6A3C0OX) PEG-8 STEARATE (UNII: 2P9L47VI5E) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TROLAMINE (UNII: 9O3K93S3TK) ARNICA MONTANA (UNII: O80TY208ZW) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape RECTANGLE (patch) Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69418-002-01 3 in 1 BOX 1 5 in 1 POUCH 1 15 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 01/24/2015 Labeler - Meds Direct Rx, Inc. (064053428) Establishment Name Address ID/FEI Business Operations Foshan Aqua Gel Biotech Co. Ltd 529128763 manufacture(69418-002)
