Tattoo Numbing Cream

Tattoo Numbing Cream
SPL v2
SPL
SPL Set ID 10262bbe-e303-d7e3-e063-6394a90aa456
Route
TOPICAL
Published
Effective Date 2024-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Aloe Lecithin, Soybean Propylene Glycol Carbomer Homopolymer, Unspecified Type Trolamine Menthol Water Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-30

Description

Tattoo Numbing Cream


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

For temporary relief of local discomfort, itching, pain, soreness, or burning in the perianal area associated with anorectal disorders.

Dosage and Administration

Adults and Children 12 years and older: 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. Apply externally to the affected area up to 6 times daily.

Description

Tattoo Numbing Cream

Section 42229-5

Tattoo Numbing Cream

Section 44425-7

Keep away from direct sunlight or heat.

Store in room temperature (59-86°F/15-30°C).

Section 50565-1

In case of accidental ingestion, seek madical attention immediately.

Section 50566-9

Condition worsens, or does not improve within 7 days. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation,swelling, pain, or other symptoms develop or increase, discontinue use.

Section 50567-7

Do not exceed the recommended daily dosage unless directed by a doctor.

Do not put into the rectum by using fingers or any medical device or applicator.

Section 50570-1

Pregnant or breastfeeding, ask a health professional before use.

Section 51727-6

Aloe barbadebsis leaf juice (Aloe vera)

Water

Lecithin (Soybean)

Propylene Glycol

Tocopheryl Acetate

Carbomer

Menthol

Triethanolamine

Section 51945-4

Section 55105-1

Topical Anesthetic

Section 55106-9

Lidocaine 5%


Structured Label Content

Indications and Usage (34067-9)

For temporary relief of local discomfort, itching, pain, soreness, or burning in the perianal area associated with anorectal disorders.

Dosage and Administration (34068-7)

Adults and Children 12 years and older: 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. Apply externally to the affected area up to 6 times daily.

Warnings and Precautions (34071-1)

For external use only

Section 42229-5 (42229-5)

Tattoo Numbing Cream

Section 44425-7 (44425-7)

Keep away from direct sunlight or heat.

Store in room temperature (59-86°F/15-30°C).

Section 50565-1 (50565-1)

In case of accidental ingestion, seek madical attention immediately.

Section 50566-9 (50566-9)

Condition worsens, or does not improve within 7 days. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation,swelling, pain, or other symptoms develop or increase, discontinue use.

Section 50567-7 (50567-7)

Do not exceed the recommended daily dosage unless directed by a doctor.

Do not put into the rectum by using fingers or any medical device or applicator.

Section 50570-1 (50570-1)

Pregnant or breastfeeding, ask a health professional before use.

Section 51727-6 (51727-6)

Aloe barbadebsis leaf juice (Aloe vera)

Water

Lecithin (Soybean)

Propylene Glycol

Tocopheryl Acetate

Carbomer

Menthol

Triethanolamine

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Anesthetic

Section 55106-9 (55106-9)

Lidocaine 5%


Advanced Ingredient Data


Raw Label Data

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