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Soothee Patch

Drug Facts

Approved
Approval ID

aed1e7c1-6197-4152-ae5e-06cf2ec3020f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 19, 2015

Manufacturers
FDA

Better Pain Solutions, LLC

DUNS: 079703680

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

LIDOCAINE, MENTHOL, CAPSAICIN, METHYL SALICYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69592-001
Product Classification
G
Generic Name
LIDOCAINE, MENTHOL, CAPSAICIN, METHYL SALICYLATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 19, 2015
FDA Product Classification

INGREDIENTS (14)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM POLYACRYLATE (2500000 MW)Inactive
Code: 05I15JNI2J
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
LIDOCAINEActive
Quantity: 0.5 mg in 10 g
Code: 98PI200987
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MENTHOLActive
Quantity: 5 mg in 10 g
Code: L7T10EIP3A
Classification: ACTIB
CAPSAICINActive
Quantity: 0.0375 g in 10 g
Code: S07O44R1ZM
Classification: ACTIB
METHYL SALICYLATEActive
Quantity: 2 g in 10 g
Code: LAV5U5022Y
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
DIAZOLIDINYL UREAInactive
Code: H5RIZ3MPW4
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
IODOPROPYNYL BUTYLCARBAMATEInactive
Code: 603P14DHEB
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT

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Soothee Patch - FDA Drug Approval Details