ASPERFLEX ORIGINAL MAXIMUM STRENGTH- menthol patch 
Akron Pharma 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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Asperflex
Maximum Strength
Tough on Pain
Menthol 7.5% Original

DRUG FACTS

Active Ingredient

Menthol 7.5%

Purpose

Topical analgesic

Uses

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

■ arthritis ■ simple backache ■ strains ■ sprains ■ bruises

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 mucous membranes
  • rare cases of serious burns 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 a medicated patch to the area of use
  • do not use at the same time as 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

■ severe burning sensation, redness or irritation develop

■ you experience signs of skin injury, such as 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).

Directions

adults and children 12 years of age and older:

■ 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 finish applying to skin

■ apply to affected area not more than 3 to 4 times daily

children under 12 years of age: consult a doctor

Other Information

store at room temperature 15°-30°C (59°-86°F).

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.

Carton

ASPERFLEX ORIGINAL MAXIMUM STRENGTH 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-4461
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL210 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71399-4461-55 in 1 CARTON11/04/2021
11 in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/04/2021
Labeler - Akron Pharma Inc. (067878881)

Revised: 2/2023
Document Id: 2a890e2e-7156-434e-95b1-9a3b9c03d91a
Set id: d766c61e-c48b-4aff-97b0-678159479e03
Version: 2
Effective Time: 20230212
 
Akron Pharma Inc.