Hot And Cold Lidocaine With Menthol Patch

Hot And Cold Lidocaine With Menthol Patch
SPL v2
SPL
SPL Set ID 5b41db97-fd9d-4eb6-b935-a1e4e806d2da
Route
TOPICAL
Published
Effective Date 2019-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (240 mg) Menthol (60 mg)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Edetate Disodium Anhydrous Glycerin Methylparaben Polyvinyl Alcohol, Unspecified Propylparaben Water Carboxymethylcellulose Sodium, Unspecified Form Sodium Polyacrylate (2500000 Mw) Tartaric Acid Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-11-22

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of Reach of children. If swallowed, get medical help or contact a Poison control Center right away.

Section 50570-1

Do not use if you are allergic or sensitive to lidocaine or menthol. Do not use if pouch is damaged or opened.

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active Ingredients Purpose
Lidocaine 4 % (240 mg) Topical analgesic
Menthol 1%     (60 mg) Topical analgesic

Warnings

For external use only.

Directions
  • adults: apply patch to affected area for a maximum of 12 hours. Do not use more than 1 patch every 24 hours.
  • children: consult your physician
  • remove protective film, gently apply to affected area.
Inactive Ingredients

Dihydroxyaluminium aminoacetate, disodium EDTA, glycerin, methylparaben, polyvinyl alcohol, propyl

paraben, propylene glycol, purified water, sodium carboxymethyl cellulose, sodium polyacrylate, tartaric

acid, titanium dioxide

When Using This Product
  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not apply to open wounds or sensitive skin
  • do not bandage tightly or use a heating pad
Stop Use and Ask A Doctor If
  • excessive redness or irritation is present
  • condition worsens
  • pain persists for more than 7 days
  • symptoms clear up and occur again within a few days

Structured Label Content

Uses

Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of Reach of children. If swallowed, get medical help or contact a Poison control Center right away.

Section 50570-1 (50570-1)

Do not use if you are allergic or sensitive to lidocaine or menthol. Do not use if pouch is damaged or opened.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active Ingredients Purpose
Lidocaine 4 % (240 mg) Topical analgesic
Menthol 1%     (60 mg) Topical analgesic

Warnings

For external use only.

Directions
  • adults: apply patch to affected area for a maximum of 12 hours. Do not use more than 1 patch every 24 hours.
  • children: consult your physician
  • remove protective film, gently apply to affected area.
Inactive Ingredients

Dihydroxyaluminium aminoacetate, disodium EDTA, glycerin, methylparaben, polyvinyl alcohol, propyl

paraben, propylene glycol, purified water, sodium carboxymethyl cellulose, sodium polyacrylate, tartaric

acid, titanium dioxide

When Using This Product (When using this product)
  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not apply to open wounds or sensitive skin
  • do not bandage tightly or use a heating pad
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • excessive redness or irritation is present
  • condition worsens
  • pain persists for more than 7 days
  • symptoms clear up and occur again within a few days

Advanced Ingredient Data


Raw Label Data

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