MedPath

Veltrix

Veltrix Pain Relieiving Cream

Approved
Approval ID

1ac45dcf-6100-1a8b-e054-00144ff8d46c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 13, 2015

Manufacturers
FDA

Home Aide Diagnostics, Inc.

DUNS: 783518983

Products 1

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

Veltrix Pain Relieiving Cream

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69379-004
Product Classification
G
Generic Name
Veltrix Pain Relieiving Cream
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 13, 2015
FDA Product Classification

INGREDIENTS (2)

LIDOCAINEActive
Quantity: 4 g in 100 g
Code: 98PI200987
Classification: ACTIB
MENTHOLActive
Quantity: 1 g in 100 g
Code: L7T10EIP3A
Classification: ACTIB

Drug Labeling Information

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/1/2015

INDICATIONS
For the temporary relief of pain of muscles and joints associated with:

  • Arthritis
  • Simple Backache
  • Strains
  • Sprains
  • Bruises

DIRECTIONS
Adults and children over 12 years
Apply generously to affected area
Massage into painful area until thoroughly absorbed into skin, repeat as necessary, not more than 3-4 times daily
Store at 20°-25°C (68°-77 °F). Avoid direct sunlight.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/1/2015

INACTIVE INGREDIENTS
aliphatic alcohol; stearic acid; vaseline; peregal; Carmellose; odium; water

INFORMATION FOR PATIENTS SECTION

LOINC: 34076-0Updated: 7/1/2015

PURPOSE: Topical analgesic

ACTIVE INGREDIENTS
Lidocain 4%

Topical analgesic
Menthol 1%

Topical analgesic

WARNINGS SECTION

LOINC: 34071-1Updated: 7/1/2015

WARNINGS
FOR EXTERNAL USE ONLY.

  • When using this product use only as directed
  • Do not bandage tightly
  • Do not use with a heating pad
  • Agoid contact with the eyes or mucous membranes
  • Do not apply to wounds or damaged or irritated skin

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 7/1/2015
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
  • If pregnant of breast-feeding, ask a healthcare professional before use

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Veltrix - FDA Drug Approval Details