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NDC 63187-0067-30 MEDI-SULTING TOPICAL PAIN RELIEF .035; .5; 5; 20 g/100g; g/100g; g/100g; g/100g Details

MEDI-SULTING TOPICAL PAIN RELIEF .035; .5; 5; 20 g/100g; g/100g; g/100g; g/100g

MEDI-SULTING TOPICAL PAIN RELIEF is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is CAPSAICIN; LIDOCAINE; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE.

Product Information

NDC	63187-0067
Product ID	63187-067_190ec4f5-eac7-45b0-b70a-d8d64a146264
Associated GPIs	90859904505930
GCN Sequence Number	070099
GCN Sequence Number Description	lidocain/me-salicyl/caps/menth ADH. PATCH 0.5 %-20 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	33406
HICL Sequence Number	037249
HICL Sequence Number Description	LIDOCAINE/METHYL SALICYLATE/CAPSAICIN/MENTHOL
Brand/Generic	Generic
Proprietary Name	MEDI-SULTING TOPICAL PAIN RELIEF
Proprietary Name Suffix	n/a
Non-Proprietary Name	METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE
Product Type	HUMAN OTC DRUG
Dosage Form	PATCH
Route	TOPICAL
Active Ingredient Strength	.035; .5; 5; 20
Active Ingredient Units	g/100g; g/100g; g/100g; g/100g
Substance Name	CAPSAICIN; LIDOCAINE; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Labeler Name	Proficient Rx LP
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63187-0067-30 (63187006730)

Pricing Information	N/A
NDC Package Code	63187-067-30
Billing NDC	63187006730
Package	30 PATCH in 1 BOX (63187-067-30) / 10 g in 1 PATCH
Marketing Start Date	2014-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4c5c0ed8-fe43-4693-83f3-25b6c16b74c6 Details

SPL UNCLASSIFIED SECTION

CAPSAICIN 0.035%

LIDOCAINE 0.5%

MENTHOL 5%

METHYL SALICYLATE 20%

SPL UNCLASSIFIED SECTION

PURPOSE

TOPICAL ANALGESIC

TOPICAL ANESTHETIC

SPL UNCLASSIFIED SECTION

USES: FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, SPRAINS, MUSCLE SORENESS AND STIFFNESS.

SPL UNCLASSIFIED SECTION

DO NOT USE: ON WOUNDS OR DAMAGED SKIN. CHILDREN UNDER 12 YEARS OLD, CONSULT A DOCTOR. IF YOU ARE ALLERGIC TO ANY INGREDIENTS IN THIS PRODUCT.

SPL UNCLASSIFIED SECTION

Directions: Use only as directed. Prior to first use, test skin sensitivity by applying a small amount. Apply and massage directly to affected area. Do not use more than 4 times a day. Thoroughly wash hands after application.

SPL UNCLASSIFIED SECTION

Inactive Ingredients: ACRLIC ACID, ALUMINUM HYDROXIDE, CARMELLOSE SODIEM, 2-ETHYLHEXYL ACRYLATE, GLYCERIN, ISOPROPYL MYRISTATE, METHYL ACRYLATE, NONOXYNOL-30, POLYACRYLATE, POLYACRYLIC ACID, POLYSORBATE 80, SORBITAN SESQUIOLEATE, STARCH, TALC, TARTARIC ACID, TITANIUM DIOXIDE, WATER.

SPL UNCLASSIFIED SECTION

OTHER INFORMATION: STORE BELOW 90°F/32°C

SPL UNCLASSIFIED SECTION

QUESTIONS? 888 907-2833

SPL UNCLASSIFIED SECTION

IF CONDITION WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE OF THIS PRODUCT AND CONSULT A DOCTOR.

SPL UNCLASSIFIED SECTION

IF PREGNANT OR NURSING ASK A HEALTH PROFESSIONAL BEFORE USE.

SPL UNCLASSIFIED SECTION

KEEP OUT OF REACH OF CHILDREN.

Warnings

Warnings: For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Do not use with heating devices or pads. Do not cover or bandage tightly. If swallowed, call poison control. If contact does occur with eyes rinse with cold water and call a doctor.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDI-SULTING TOPICAL PAIN RELIEF

methyl salicylate menthol capsaicin lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-067(NDC:76074-123)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	20 g in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	5 g in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	.035 g in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ACRYLIC ACID (UNII: J94PBK7X8S)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ETHYLHEXYL ACETATE (UNII: 2C7K8OA8SB)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYL ACRYLATE (UNII: WC487PR91H)
NONOXYNOL-30 (UNII: JJX07DG188)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63187-067-30	30 in 1 BOX	06/01/2014
1		10 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/18/2012

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	RELABEL(63187-067) , REPACK(63187-067)

Revised: 12/2019

Document Id: 190ec4f5-eac7-45b0-b70a-d8d64a146264

Set id: 4c5c0ed8-fe43-4693-83f3-25b6c16b74c6

Version: 2

Effective Time: 20191201

Search by Drug Name or NDC

NDC 63187-0067-30 MEDI-SULTING TOPICAL PAIN RELIEF .035; .5; 5; 20 g/100g; g/100g; g/100g; g/100g Details

MEDI-SULTING TOPICAL PAIN RELIEF .035; .5; 5; 20 g/100g; g/100g; g/100g; g/100g

Product Information

Package

Package Images

NDC 63187-0067-30 (63187006730)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 4c5c0ed8-fe43-4693-83f3-25b6c16b74c6 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Warnings

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

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