ASPERFLEX ORIGINAL MAXIMUM STRENGTH- menthol patch

AsperFlex Original Maximum Strength by

Drug Labeling and Warnings

AsperFlex Original Maximum Strength by is a Otc medication manufactured, distributed, or labeled by Akron Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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)