AsperFlex™ HOT Pain Relief Patch

AsperFlex™ HOT Pain Relief Patch

Asperflex is used for the temporary relief of minor aches and pains, including backaches, sore shoulders, stiff necks and joint pain. Each patch contains three powerful pain fighters, including Camphor, Menthol and Methyl Salicylate. Each patch contains 4% Lidocaine.

Category:

Description

NDC: 71399-4439-06

ASPERFLEX HOT Pain Relief Patch

Active Ingredients: Capsicum extract 0.025% as Capsaicin – Menthol 1.25%

Topical Anesthetic

Purpose:

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

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

Dosage and Administration Directions:

Adults and children over 12 years:

  • 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 physician.

For external use only.

WARNINGS:

Do not use:

  • on wounds or damaged skin.
  • with a heating pad.
  • if you are allergic to any ingredients of 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

  • rash, itching or excessive skin irritation develops.
  • condition worsens.
  • 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).

 

ASPERFLEX HOT camphor, menthol, methyl salicylate patch
PRODUCT INFORMATION
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71399-4439
Route of Administration TOPICAL, PERCUTANEOUS, TRANSDERMAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM – UNII:00UK7646FG) CAPSICUM 0.025 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL – UNII:L7T10EIP3A) MENTHOL 1.25 g  in 100 g
INACTIVE INGREDIENTS
Ingredient Name Strength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM ACRYLATE (UNII: 7C98FKB43H)
TARTARIC ACID (UNII: W4888I119H)
HYDANTOIN (UNII: I6208298TA)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:71399-4439-6 6 in 1 BOX 11/04/2021
1 7 g in 1 PATCH; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 11/04/2021
LABELER – AKRON PHARMA INC. (067878881)

 

 

Questions? Please Call 1(877) 225-6999

Manufactured for: Akron Pharma, Inc. Fairfield, NJ 07004 Manufactured in the United States.