Asperflex

Asperflex
SPL v3
SPL
SPL Set ID d766c61e-c48b-4aff-97b0-678159479e03
Route
TOPICAL
Published
Effective Date 2023-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (210 mg)
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

Menthol 7.5%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 7.5%

Uses

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

■ arthritis ■ simple backache ■ strains ■ sprains ■ bruises

Section 51945-4

Warnings

For external use only

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

Do Not Use

■ on wounds, damaged, broken or irritated skin

■ with a heating pad or apply local heat to the area of use

Active Ingredient

Menthol 7.5%

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.

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).


Structured Label Content

Uses

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

■ arthritis ■ simple backache ■ strains ■ sprains ■ bruises

Section 51945-4 (51945-4)

Purpose

Topical analgesic

Warnings

For external use only

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

Do Not Use (Do not use)

■ on wounds, damaged, broken or irritated skin

■ with a heating pad or apply local heat to the area of use

Active Ingredient

Menthol 7.5%

Other Information

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

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.

When Using This Product (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 (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, (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

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