Leader Burn Relief Spray, Lidocaine 0.5%

Leader Burn Relief Spray, Lidocaine 0.5%
SPL v2
SPL
SPL Set ID f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2
Route
TOPICAL
Published
Effective Date 2023-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.5 g)
Inactive Ingredients
Water Glycerin Alcohol Propylene Glycol Edetate Disodium Trolamine Aloe Vera Leaf Carbomer 940 Polysorbate 80 Diazolidinyl Urea Propylparaben Silicon Dioxide Disodium Cocoamphodipropionate Methylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-17

Description

Lidocaine 0.5%


Medication Information

Warnings and Precautions

For external use only.

Flammable--do not use while smoking or near heat or flame. Do not use in large quantities, particularly over raw surfaces or blistered areas.

When using this product avoid contact with eyes. Rinse with water to remove. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.

Stop use and ask a doctor if the condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

Indications and Usage

Shake well before use. Adults and children 2 years and older: apply to the affected area, not more than 3 to 4 times a day. Children under 2 years of age: ask a doctor. To apply to face, spray in palm of hand and gently apply.

Dosage and Administration

For the temporary relief of pain and itching due to sunburn, minor burns, insect bites, minor cuts, scrapes, and minor skin irritations.

Description

Lidocaine 0.5%

Section 50565-1

Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Water, Alcohol Denat., Propylene Glycol, Glycerin, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Disodium Cocoamphodipipropionate, Carbomer, Disodium EDTA, Triethanolamine, Diazolidinyl Urea, Propylparaben, methylparaben, Simethicone.

Section 51945-4

Section 55105-1

External Analgesic.

Section 55106-9

Lidocaine 0.5%


Structured Label Content

Indications and Usage (34067-9)

Shake well before use. Adults and children 2 years and older: apply to the affected area, not more than 3 to 4 times a day. Children under 2 years of age: ask a doctor. To apply to face, spray in palm of hand and gently apply.

Dosage and Administration (34068-7)

For the temporary relief of pain and itching due to sunburn, minor burns, insect bites, minor cuts, scrapes, and minor skin irritations.

Warnings and Precautions (34071-1)

For external use only.

Flammable--do not use while smoking or near heat or flame. Do not use in large quantities, particularly over raw surfaces or blistered areas.

When using this product avoid contact with eyes. Rinse with water to remove. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.

Stop use and ask a doctor if the condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50565-1 (50565-1)

Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Water, Alcohol Denat., Propylene Glycol, Glycerin, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Disodium Cocoamphodipipropionate, Carbomer, Disodium EDTA, Triethanolamine, Diazolidinyl Urea, Propylparaben, methylparaben, Simethicone.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

External Analgesic.

Section 55106-9 (55106-9)

Lidocaine 0.5%


Advanced Ingredient Data


Raw Label Data

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