nufabrx foot/ankle sleeve 72490-010

nufabrx foot/ankle sleeve 72490-010
SPL v5
SPL
SPL Set ID a6688555-d2a0-148b-e053-2a95a90a99ad
Route
topical
Published
Effective Date 2019-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
capsaicin (0.12 g)
Inactive Ingredients
butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-05-11

Purpose

Topical Analgesic

Description

Capsaicin (Nonivamide) 0.12%


Medication Information

Warnings

For external use only

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

Directions
  • Clean and dry affected area
  • Remove sleeve from packaging and place on foot
  • 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
Other Information

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

Inactive Ingredients

Acrylates Copolymer

Description

Capsaicin (Nonivamide) 0.12%

Principal Display Panel

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

Capsaicin (Nonivamide) 0.12%

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

Warnings

For external use only

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

Directions
  • Clean and dry affected area
  • Remove sleeve from packaging and place on foot
  • 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
Other Information

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

Inactive Ingredients

Acrylates Copolymer

Principal Display Panel

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

Capsaicin (Nonivamide) 0.12%

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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