NUFABRX KNEE SLEEVE- capsaicin cloth

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)
Available from:
Textile-Based Delivery, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical Analgesic For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache, arthritis, strains, bruises, and sprains.
Authorization status:
OTC monograph not final
Authorization number:
72490-002-01, 72490-002-02, 72490-002-03, 72490-002-04, 72490-002-05, 72490-002-06, 72490-002-07, 72490-002-08, 72490-002-09

NUFABRX KNEE SLEEVE- capsaicin cloth

Textile-Based Delivery, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Nufabrx Knee Sleeve

Active Ingredient

Synthetic Capsaicin 0.23%

Purpos e

Topical Analgesic

Us es

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

Do not use

Allergy Alert: if you are allergic to any ingredients of this product or chili peppers contact a doctor

before use

On wounds or to damaged skin

With, or at same time as, other analgesic products

With a heating pad

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 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

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.

Directions

Clean and dry affected area

Remove sleeve from packaging and place on knee

Maximum use of 8 hours per day. Remove sleeve after 8 hours of wear

Wear knee sleeve daily, but not more than 4 times per week

Wash separately from other clothing

Other Information

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

Inactive Ingredients

Acrylates Copolymer

Principal Display Panel

NUFABRX KNEE SLEEVE

capsaicin cloth

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7249 0 -0 0 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CAPSAICIN (UNII: S0 7O44R1ZM) (CAPSAICIN - UNII:S0 7O44R1ZM)

CAPSAICIN

0 .23

Inactive Ingredients

Ingredient Name

Stre ng th

BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID CO PO LYMER ( 18 0 0 0 MW) (UNII:

JZ1374NL9 E)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7249 0 -0 0 2-0 1

1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 1/14/20 19

2

NDC:7249 0 -0 0 2-0 2

1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 1/14/20 19

3

NDC:7249 0 -0 0 2-0 3

1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 1/14/20 19

Textile-Based Delivery, Inc.

4

NDC:7249 0 -0 0 2-0 4

1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 4/29 /20 19

5

NDC:7249 0 -0 0 2-0 5

1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 4/29 /20 19

6

NDC:7249 0 -0 0 2-0 6

1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 4/29 /20 19

7

NDC:7249 0 -0 0 2-0 7

1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 4/29 /20 19

8

NDC:7249 0 -0 0 2-0 8

1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 4/29 /20 19

9

NDC:7249 0 -0 0 2-0 9

1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 4/29 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 1/14/20 19

Labeler -

T extile-Based Delivery, Inc. (079309716)

Revised: 12/2019

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