SPL v1
SPL
SPL Set ID d7e394b6-3e88-445b-82eb-3b89d70eb8b3
Route
TOPICAL
Published
Effective Date 2023-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Water Butylene Glycol Diethylene Glycol Monoethyl Ether Ammonium Acryloyldimethyltaurate/vp Copolymer Squalane Aloe Vera Leaf Allantoin Tocopherol Avocado Oil 2-hydroxyethyl Acrylate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Phenoxyethanol Xanthan Gum Ethylhexylglycerin Lecithin, Soybean Tricaprin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-01-05

Description

Lidocaine HCl 5%

Purpose

Topical analgesic/Anesthetic


Medication Information

Purpose

Topical analgesic/Anesthetic

Description

Lidocaine HCl 5%

Uses

For the temporary relief of minor pain, irritation and itching

Section 50565-1

Warnings

For external use only.

When using this product Avoid contact with eyes.

Do not apply to wounds or damaged, broken or irritated skin

Stop use and ask a doctor If• Condition worsens. • Irritation develops. Redness appears. • Symptoms persist for more than 7 days or clear up and occurs again within a few days.

Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away. Emergency Number: 1-800-222-1222

IF PREGNANT OR BREASTFEEDING, ask a heath professional before use

Directions

Adults and children over 12 years:

• Apply a thin layer to affected area every 6 to 8 hours.

• Wash hands with soap and water immediately after use.

• Children 12 years or younger: ask a doctor.

Product Label

Active Ingredient

Lidocaine HCl 5%

Other Information

Store at 15•-30• C (59'-86' F).

Inactive Ingredients

Aqua, Caprylic/Capric Triglyceride, Butylene Glycol, Ethoxydiglycol, Ammonium AcryloyldimethyltaurateNP Copolymer, Squalane, Aloe Barbadensis (Aloe Vera) Leaf Juice, Allantoin, Tocopherol (Vitamin E), Persea Gratissima (Avocado) Oil, Hydroxyethyl Acrylate, Sodium Acryloyldimethyl Tau rate Copolymer, Polyacrylate Crosspolymer-6, Phenoxyethanol, Xanthan Gum, Ethylhexylglycerin, Lecithin.

Questions and Comments 

855-700-0660


Structured Label Content

Uses

For the temporary relief of minor pain, irritation and itching

Section 50565-1 (50565-1)

Purpose

Topical analgesic/Anesthetic

Warnings

For external use only.

When using this product Avoid contact with eyes.

Do not apply to wounds or damaged, broken or irritated skin

Stop use and ask a doctor If• Condition worsens. • Irritation develops. Redness appears. • Symptoms persist for more than 7 days or clear up and occurs again within a few days.

Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away. Emergency Number: 1-800-222-1222

IF PREGNANT OR BREASTFEEDING, ask a heath professional before use

Directions

Adults and children over 12 years:

• Apply a thin layer to affected area every 6 to 8 hours.

• Wash hands with soap and water immediately after use.

• Children 12 years or younger: ask a doctor.

Product Label (Product label)

Active Ingredient

Lidocaine HCl 5%

Other Information

Store at 15•-30• C (59'-86' F).

Inactive Ingredients (Inactive ingredients)

Aqua, Caprylic/Capric Triglyceride, Butylene Glycol, Ethoxydiglycol, Ammonium AcryloyldimethyltaurateNP Copolymer, Squalane, Aloe Barbadensis (Aloe Vera) Leaf Juice, Allantoin, Tocopherol (Vitamin E), Persea Gratissima (Avocado) Oil, Hydroxyethyl Acrylate, Sodium Acryloyldimethyl Tau rate Copolymer, Polyacrylate Crosspolymer-6, Phenoxyethanol, Xanthan Gum, Ethylhexylglycerin, Lecithin.

Questions and Comments  (Questions and comments )

855-700-0660


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)