72490-035 Nufabrx Back Wrap

72490-035 Nufabrx Back Wrap
SPL v6
SPL
SPL Set ID e4f85ac8-57cb-46eb-e053-2995a90a9b1c
Route
TOPICAL
Published
Effective Date 2022-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.14 g)
Inactive Ingredients
Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw)

Identifiers & Packaging

Pill Appearance
Color: black
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-29

Description

Capsaicin (Nonivamide) 0.14%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Capsaicin (Nonivamide) 0.14%

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with: Simple backache, arthritis, strains, bruises and sprains.

Warnings

For external use only

Directions
  • Clean and dry affected area
  • Remove sleeve from packaging and place on lower leg
  • Maximum use of 10 hours per day
  • Wash separately from other clothing
  • Do not wear more than 6 days straight without doctor consent
Do Not Use
  • If you are allergic to any ingredients of this product or chili peppers, contact a doctor before use (allergy alert)
  • On wounds or damaged skin
  • With, or at the same time as, other external analgesic products
  • With a heating pad
Package Label

Active Ingredient

Capsaicin (Nonivamide) 0.14%

Other Information

Avoid storing product in direct sunlight. Protect product from excessive moisture.

Inactive Ingredients

Acrylate copolymer

When Using This Product
  • You may experience a burning sensation which is normal and related to the way the product works (with regular use, this sensation generally diminishes)
  • Do not use immediately before or after activities such as swimming, showering, sunbathing or intense exercise
  • Use only as directed
  • Avoid contact with eyes and mucous membranes or rashes
Stop Use and Ask Doctor If
  • Condition worsens, symptoms persist more than 7 days or clear up and occur again within a few days
  • Rash, itching or excessive skin irritation develops
If Pregnant Or Breastfeeding

Consult a healthcare professional before use

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away


Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with: Simple backache, arthritis, strains, bruises and sprains.

Purpose

Topical Analgesic

Warnings

For external use only

Directions
  • Clean and dry affected area
  • Remove sleeve from packaging and place on lower leg
  • Maximum use of 10 hours per day
  • Wash separately from other clothing
  • Do not wear more than 6 days straight without doctor consent
Do Not Use (Do not use)
  • If you are allergic to any ingredients of this product or chili peppers, contact a doctor before use (allergy alert)
  • On wounds or damaged skin
  • With, or at the same time as, other external analgesic products
  • With a heating pad
Package Label

Active Ingredient (Active ingredient)

Capsaicin (Nonivamide) 0.14%

Other Information (Other information)

Avoid storing product in direct sunlight. Protect product from excessive moisture.

Inactive Ingredients (Inactive ingredients)

Acrylate copolymer

When Using This Product (When using this product)
  • You may experience a burning sensation which is normal and related to the way the product works (with regular use, this sensation generally diminishes)
  • Do not use immediately before or after activities such as swimming, showering, sunbathing or intense exercise
  • Use only as directed
  • Avoid contact with eyes and mucous membranes or rashes
Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • Condition worsens, symptoms persist more than 7 days or clear up and occur again within a few days
  • Rash, itching or excessive skin irritation develops
If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

Consult a healthcare professional before use

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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