Aspeflex

Aspeflex
SPL v3
SPL
SPL Set ID ab50525e-b534-452b-8c25-2992c0cbf862
Route
TOPICAL
Published
Effective Date 2025-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Anhydrous Glycerin Edetate Disodium Kaolin Methylparaben Polyacrylic Acid (250000 Mw) Polysorbate 80 Propylene Glycol Propylparaben Povidone K90 Sodium Polyacrylate (2500000 Mw) Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-04

Description

Lidocaine 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4%

Uses

for the temporary relief of pain

Section 51945-4

Warnings

For external use only

Directions

a dults and children over 12 years:

  • clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • use 1 patch at a time and not more than 3 to 4 times daily

children 12 years or younger: consult a doctor

Do Not Use
  • on puncture wounds, cuts, irritated or swollen skin
  • more than 1 patch on your body at a time or with other topical analgesics at the same time
  • with a heating pad or apply local heat to the area of use
Drug Facts

Active Ingredient

Lidocaine 4%

Other Information

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

Inactive Ingredients

Dihydroxyaluminum Aminoacetate Anhydrous, Edetate Disodium, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PolyvinylPyrrolidone K90, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

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
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch
Questions Or Comments? 

Call toll-free 1-877-255-6999.

Manufactured for:

Akron Pharma Inc.,

Fairfield, NJ-07004

www.akronpharma.com

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
  • redness or irritation develops
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a health professional before use.


Structured Label Content

Uses

for the temporary relief of pain

Section 51945-4 (51945-4)

Purpose

Topical anesthetic

Warnings

For external use only

Directions

a dults and children over 12 years:

  • clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • use 1 patch at a time and not more than 3 to 4 times daily

children 12 years or younger: consult a doctor

Do Not Use (Do not use)
  • on puncture wounds, cuts, irritated or swollen skin
  • more than 1 patch on your body at a time or with other topical analgesics at the same time
  • with a heating pad or apply local heat to the area of use
Drug Facts

Active Ingredient

Lidocaine 4%

Other Information

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

Inactive Ingredients (Inactive ingredients)

Dihydroxyaluminum Aminoacetate Anhydrous, Edetate Disodium, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PolyvinylPyrrolidone K90, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

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
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch
Questions Or Comments?  (Questions or Comments? )

Call toll-free 1-877-255-6999.

Manufactured for:

Akron Pharma Inc.,

Fairfield, NJ-07004

www.akronpharma.com

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
  • redness or irritation develops
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
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).

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

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