Label: PAIN RELIEF- lidocaine hydrochloride,menthol,methyl salicylate patch
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Contains inactivated NDC Code(s)
NDC Code(s): 70355-001-09, 70355-001-10, 70355-001-11, 70355-001-12, view more70355-001-13, 70355-001-14, 70355-001-15, 70355-001-16 - Packager: ZHEJIANG DONGYANG YINDA BIOLOGY CO., LTD
- 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 January 6, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
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WARNINGS
Warnings
For external use only
Do not use ·on the face or rashes·on open wounds, cuts, damaged or infected skin ·with a heating pad ·if allergic to any ingredients · if condition worsens or symptoms persist for more than 7 days ·excessive skin irritation occurs
Ask a doctor before use if: .you are allergic to any ingredients ·you have high blood pressure,heart disease,or kidney disease ·you are pregnant
When using this product: avoid contact with eyes, genitals, and other mucus membranes. If eye contact occurs, rinse thoroughly with water.
If pregnant or breast-feeding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive Ingredients
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN RELIEF
lidocaine hydrochloride,menthol,methyl salicylate patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70355-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 4 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) TALC (UNII: 7SEV7J4R1U) TARTARIC ACID (UNII: W4888I119H) STARCH, CORN (UNII: O8232NY3SJ) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) ACRYLIC ACID (UNII: J94PBK7X8S) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) 2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYL ACRYLATE (UNII: WC487PR91H) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) NONOXYNOL-30 (UNII: JJX07DG188) POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70355-001-09 15 in 1 BOX 1 3 in 1 POUCH 1 0.408 g in 1 PATCH; Type 0: Not a Combination Product 2 NDC:70355-001-10 15 in 1 BOX 2 5 in 1 POUCH 2 0.408 g in 1 PATCH; Type 0: Not a Combination Product 3 NDC:70355-001-11 6 in 1 BOX 3 3 in 1 POUCH 3 0.408 g in 1 PATCH; Type 0: Not a Combination Product 4 NDC:70355-001-12 4 in 1 BOX 4 1 in 1 POUCH 4 0.408 g in 1 PATCH; Type 0: Not a Combination Product 5 NDC:70355-001-13 24 in 1 BOX 5 2 in 1 POUCH 5 0.85 g in 1 PATCH; Type 0: Not a Combination Product 6 NDC:70355-001-14 24 in 1 BOX 6 4 in 1 POUCH 6 0.408 g in 1 PATCH; Type 0: Not a Combination Product 7 NDC:70355-001-15 24 in 1 BOX 7 5 in 1 POUCH 7 0.408 g in 1 PATCH; Type 0: Not a Combination Product 8 NDC:70355-001-16 24 in 1 BOX 8 6 in 1 POUCH 8 0.408 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 12/30/2015 Labeler - ZHEJIANG DONGYANG YINDA BIOLOGY CO., LTD (546989657) Establishment Name Address ID/FEI Business Operations ZHEJIANG DONGYANG YINDA BIOLOGY CO., LTD 546989657 manufacture(70355-001)
