72490-012 Nufabrx Knee Sleeve

72490-012 Nufabrx Knee Sleeve
SPL v7
SPL
SPL Set ID a5f455d4-5fc5-d516-e053-2a95a90a921e
Route
TOPICAL
Published
Effective Date 2019-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.15 g)
Inactive Ingredients
Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-11

Description

Synthetic Capsaicin 0.15%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Synthetic Capsaicin 0.15%

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 knee
  • Maximum use of 8 hours per day (remove after 8 hours of wear)
  • 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 to damaged skin

With, or at same time as, other external analgesic products

With a heating pad

Active Ingredient

Synthetic Capsaicin 0.15%

Other Information

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

Inactive Ingredients

Acrylates 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
If Pregnant Or Breastfeeding

Consult a healthcare professional before use

Stop Use and Ask A 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
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 knee
  • Maximum use of 8 hours per day (remove after 8 hours of wear)
  • 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 to damaged skin

With, or at same time as, other external analgesic products

With a heating pad

Active Ingredient

Synthetic Capsaicin 0.15%

Other Information

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

Inactive Ingredients

Acrylates Copolymer

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
If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

Consult a healthcare professional before use

Stop Use and Ask A Doctor If (Stop use and ask a 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
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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