SPL v2
SPL
SPL Set ID 1138c88a-447c-644e-e063-6294a90aab3f
Route
TOPICAL
Published
Effective Date 2024-03-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Propylene Glycol Arnica Montana Flower Menthol Trideceth-6 Ethylhexylglycerin Phenoxyethanol Sunflower Oil Edetate Sodium Sodium Polyacrylate (2500000 Mw) Hydrogenated Polydecene (1500 Cst) Water Dimethyl Isosorbide Emu Oil Allantoin .alpha.-tocopherol Acetate, D- Ethylhexyl Palmitate Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s)

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-15 Until 2026-03-15

Description

WARNINGS For external use only. Stop use and ask a doctor if the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop. If pregnant or breast-feeding, ask a health professional before use. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Keep out of reach of children.


Medication Information

Warnings and Precautions

WARNINGS

For external use only.

Stop use and ask a doctor if the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop. If pregnant or breast-feeding, ask a health professional before use.

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Keep out of reach of children.

Indications and Usage

Use

For the temporary relief of pain, burning, and soreness associated with anorectal discomfort or inflammation.

Dosage and Administration

Description

WARNINGS For external use only. Stop use and ask a doctor if the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop. If pregnant or breast-feeding, ask a health professional before use. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Keep out of reach of children.

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product

Do not excceed recommended dosage unless directed by a doctor.

Section 51727-6

Inactive Ingredients

Aacrylates, Allantoin, Arnice Montana Flower Extract, Deionized Water, Dimethyl Isosorbide, Emu Oil, Ethylhexyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Polydecene, Menthol, Phenoxythanol, Propylene Glycol, Sodium Polyacrylate, Tetrasodium Edta, Tocopheryl Acetate, Trideceth-6

Section 51945-4

Section 53413-1

Questions or concerns?

Contact [email protected] or 714-582-2715.

Section 55105-1

Use

For the temporary relief of pain, burning, and soreness associted with anorectal discomfort or inflammation.

Section 55106-9

Active Ingredients

Lidocaine 5% local anesthetic

Section 59845-8

Directions

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. For products for external use only. Apply up to 6 times a day. Children under 12 years of age: consult a doctor.

Section 60561-8

Other Information

Store at 59F to 86F (15C to 30C). Keep away from direct sunlight.


Structured Label Content

Indications and Usage (34067-9)

Use

For the temporary relief of pain, burning, and soreness associated with anorectal discomfort or inflammation.

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

WARNINGS

For external use only.

Stop use and ask a doctor if the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop. If pregnant or breast-feeding, ask a health professional before use.

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Keep out of reach of children.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product

Do not excceed recommended dosage unless directed by a doctor.

Section 51727-6 (51727-6)

Inactive Ingredients

Aacrylates, Allantoin, Arnice Montana Flower Extract, Deionized Water, Dimethyl Isosorbide, Emu Oil, Ethylhexyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Polydecene, Menthol, Phenoxythanol, Propylene Glycol, Sodium Polyacrylate, Tetrasodium Edta, Tocopheryl Acetate, Trideceth-6

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or concerns?

Contact [email protected] or 714-582-2715.

Section 55105-1 (55105-1)

Use

For the temporary relief of pain, burning, and soreness associted with anorectal discomfort or inflammation.

Section 55106-9 (55106-9)

Active Ingredients

Lidocaine 5% local anesthetic

Section 59845-8 (59845-8)

Directions

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. For products for external use only. Apply up to 6 times a day. Children under 12 years of age: consult a doctor.

Section 60561-8 (60561-8)

Other Information

Store at 59F to 86F (15C to 30C). Keep away from direct sunlight.


Advanced Ingredient Data


Raw Label Data

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