Theraworx Pain Relief Roll- On- Lidocaine

Theraworx Pain Relief Roll- On- Lidocaine
SPL v1
SPL
SPL Set ID b4ce3876-f9e3-43ca-810b-75fbe6f887b6
Route
TOPICAL
Published
Effective Date 2023-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Allantoin Aloe Vera Leaf Water Benzyl Alcohol Citric Acid Monohydrate Cocamidopropyl Betaine Decyl Glucoside Dimethyl Sulfoxide Ethylhexylglycerin Glycerin Potassium Sorbate Sanguinaria Canadensis Root Sodium Benzoate Edetate Sodium Xanthan Gum Yeast, Unspecified Ginger

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-15

Description

Lidocaine Hydrochloride 4.00%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Lidocaine Hydrochloride 4.00%

Uses

For temporary relief of pain

Warnings

For external use only.

Directions
  • Adults and children 2 years of age and older:
  • shake bottle well
  • roll a thin layer to each affected area and allow to air dry
  • repeat
  • Wash hands after applying product
  • do not use more than 3 to 4 times daily
  • children under 2 years of age do not use: consult a doctor
Do Not Use

in large quantities, particularly over raw surfaces or blistered areas

Drug Facts

Active Ingredient

Lidocaine Hydrochloride 4.00%

Other Information

Store between 32°F and 120°F

Package Labeling:

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor If

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away

Inactive Ingredients (alphabetical)

Allantoin, Aloe barbadensis Leaf Extract, Aqua (Water), Benzyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Decyl Glucoside, Dimethyl Sulfoxide, Ethylhexylglycerin, Glycerin, Potassium Sorbate, Sanguinaria canadensis Root Extract, Silver Hydrosol, Sodium Benzoate, Tetrasodium EDTA, Xanthan Gum, Yeast Extract, Zingiber (Ginger) Root Extract


Structured Label Content

Uses

For temporary relief of pain

Purpose

Topical analgesic

Warnings

For external use only.

Directions
  • Adults and children 2 years of age and older:
  • shake bottle well
  • roll a thin layer to each affected area and allow to air dry
  • repeat
  • Wash hands after applying product
  • do not use more than 3 to 4 times daily
  • children under 2 years of age do not use: consult a doctor
Do Not Use (Do not use)

in large quantities, particularly over raw surfaces or blistered areas

Drug Facts

Active Ingredient

Lidocaine Hydrochloride 4.00%

Other Information

Store between 32°F and 120°F

Package Labeling:

When Using This Product (When using this product)

avoid contact with the eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

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

Inactive Ingredients (alphabetical) (Inactive Ingredients (Alphabetical))

Allantoin, Aloe barbadensis Leaf Extract, Aqua (Water), Benzyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Decyl Glucoside, Dimethyl Sulfoxide, Ethylhexylglycerin, Glycerin, Potassium Sorbate, Sanguinaria canadensis Root Extract, Silver Hydrosol, Sodium Benzoate, Tetrasodium EDTA, Xanthan Gum, Yeast Extract, Zingiber (Ginger) Root Extract


Advanced Ingredient Data


Raw Label Data

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