72490-034 Nufabrx Neck Wrap

72490-034 Nufabrx Neck Wrap
SPL v8
SPL
SPL Set ID e10b420c-500d-5738-e053-2a95a90a008f
Route
TOPICAL
Published
Effective Date 2022-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.19 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 2022-06-09

Description

Capsaicin (Nonivamide) 0.19%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Capsaicin (Nonivamide) 0.19%

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 neck
  • Maximum use of 10 hours per day
  • Hand wash only
  • Do not wear more than 6 days straight without doctor consent
  • Wash hands after applying
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
Active Ingredient

Capsaicin (Nonivamide) 0.19%

Other Information

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

Inactive Ingredients

Acrylate copolymer

Principal Display Panel

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 neck
  • Maximum use of 10 hours per day
  • Hand wash only
  • Do not wear more than 6 days straight without doctor consent
  • Wash hands after applying
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
Active Ingredient (Active ingredient)

Capsaicin (Nonivamide) 0.19%

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Acrylate copolymer

Principal Display Panel (Principal display panel)

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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