AsperFlex™ Original Pain Relief Patch

NDC: 71399-4461-05

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: 71399-4461-05

ASPERFLEX Original Pain Relief Patch

Menthol 7.5%

Topical Anesthetic

Purpose:

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

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

 

Dosage and Administration Directions:

Adults and children over 12 years:

  • gently fold the patch in half to remove center section of film backing.
  • Apply the exposed adhesive portion to the site of pain.
  • remove remaining film backing from both sides and apply to skin.
  • apply to affected area no more than 3 to 4 times daily.

Children under 12 years of age: consult a physician.

 

WARNINGS:

For external use only

Do not use:

  • on wounds, damaged, broken or irritated skin
  • with a heating pad or apply local heat to the area of use

When using this product:

  • Use only as directed. Read and follow all directions and warnings on this carton.
  • Do not allow contact with the eyes and/or mucus membranes.
  • Remember that there are rare cases of serious burns that have been reported with products of this type.
  • do not apply to wounds or damaged, broken or irritated skin.
  • do not bandage tightly or apply local heat (such as heating pads) or another medicated patch to the area of use.
  • do not use together with other topical analgesics.
  • a transient burning sensation may occur upon application but generally disappears in several days.
  • avoid applying into skin folds.
  • do not use more than 4 patches at a time.

Stop use and ask a doctor if:

  • condition worsens or symptoms persist for more than 7 days.
  • symptoms clear up and occur again within a few days.
  • you experience a severe burning sensation, redness or if irritation develops.
  • you experience signs of skin injury, including pain, swelling, or blistering where the product was applied.

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).

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.

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

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

 

ASPERFLEX ORIGINAL MAXIMUM STRENGTH menthol patch
PRODUCT INFORMATION
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71399-4461
Route of Administration TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL – UNII:L7T10EIP3A) MENTHOL 210 mg
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:71399-4461-5 5 in 1 CARTON 11/04/2021
1 1 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.