Asperflex

Asperflex
SPL v3
SPL
SPL Set ID a6cb0656-8866-44ff-b40c-73655ff68721
Routes
PERCUTANEOUS TOPICAL TRANSDERMAL
Published
Effective Date 2023-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsicum (0.025 g) Menthol (1.25 g)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Anhydrous Propylene Glycol Sodium Acrylate Tartaric Acid Hydantoin Edetate Disodium Anhydrous Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-04

Description

Capsicum extract 0.025% as Capsaicin Menthol 1.25%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Capsicum extract 0.025% as Capsaicin Menthol 1.25%

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains
Section 51945-4

Warnings

For external use only

Directions

Adults and children 12 years of age and over:

  • clean and dry affected area
  • remove patch from film
  • apply to affected area not more than 3 to 4 times daily
  • remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

Do Not Use
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
Other Information
  • store at room temperature 15°-30°C (59°-86°F).
Active Ingredients

Capsicum extract 0.025% as Capsaicin

Menthol 1.25%

Inactive Ingredients

aluminum glycinate, propylene glycol, sodium acrylate/sodium acryloyldimethyl taurate copolymer, tartaric acid, 2,4-Imidazolidinedione, disodium edta, water, glycerin

Questions Or Comments?

Call toll-free 1-877-255-6999.

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

www.akronpharma.com

When Using This Product
  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
Stop Use and Ask A Doctor If
  • rash, itching or excessive skin irritation develops
  • contisions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222).


Structured Label Content

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains
Section 51945-4 (51945-4)

Purpose

Topical analgesic

Warnings

For external use only

Directions

Adults and children 12 years of age and over:

  • clean and dry affected area
  • remove patch from film
  • apply to affected area not more than 3 to 4 times daily
  • remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

Do Not Use (Do not use)
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
Other Information (Other information)
  • store at room temperature 15°-30°C (59°-86°F).
Active Ingredients (Active ingredients)

Capsicum extract 0.025% as Capsaicin

Menthol 1.25%

Inactive Ingredients (Inactive ingredients)

aluminum glycinate, propylene glycol, sodium acrylate/sodium acryloyldimethyl taurate copolymer, tartaric acid, 2,4-Imidazolidinedione, disodium edta, water, glycerin

Questions Or Comments? (Questions or comments?)

Call toll-free 1-877-255-6999.

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

www.akronpharma.com

When Using This Product (When using this product)
  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash, itching or excessive skin irritation develops
  • contisions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health 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. (1-800-222-1222).


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)