83804-005 Elaimei Numbing Cream

83804-005 Elaimei Numbing Cream
SPL v7
SPL
SPL Set ID 37ac13b2-ca55-0e28-e063-6294a90a000e
Route
TOPICAL
Published
Effective Date 2025-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Water .alpha.-tocopherol Acetate Aloe Barbadensis Leaf Propylene Glycol Triethanolamine Lecithin, Soybean Carbomer Menthol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-16

Description

Lidocaine 4%


Medication Information

Warnings and Precautions

Do not this product if pregnant or breastfeeding, ask a heaith professional before use

Indications and Usage

Uses: For temporary relief of local discomfort, itching, pain, sorenessor burning in the perianal area associated with anorectal disorders

Dosage and Administration

Adults and Children 12 years and older: When practical, cleansethe affected area with mild soap and warm water and rinsethoroughly, Gently dry by patting or blotting with toitet tissue or aSoft cloth before application of this product. Apply externally to theaffected area up to 6 times daily.

Description

Lidocaine 4%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN SECTION

Section 50566-9

Stop use and ask a doctor if Condition worsens, or does notimprove within 7 days.Certain persons can develop aliergicreactions to ingredients in this product. if the symptom beingtreated does not subside or if redness, irritation, swelling, pain, orother symptoms develop or increase, discontinue use.

Section 50567-7



CORRECT USE STEPS BEFORE TATTOOING

1.Clean hands and treatment area with mild soap and warmwater (to open pores to help absorb numbing cream), thengently dry.

2. Apply a thick layer of about 2mm to the treated area. (Makesure the tattoo area and surroundings are white cream)

3. Wrap tightly with plastic wrap, wait 60 minutes (longer fimebetter effect). lt is recommended to massage or tap iightlyevery 10 minutes to help the absorption of the numbing cream.

4.Wipe away residue, wait another 20-30 minutes for thenumbness to peak. And begin procedure.

Section 50570-1



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

Do nat put into the reclum by using fingers or any medicatd evice or applicator.

Children under 12 years of age, consult a doctor.

Section 51727-6

Aloe barbadensis 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 4%


Structured Label Content

Indications and Usage (34067-9)

Uses: For temporary relief of local discomfort, itching, pain, sorenessor burning in the perianal area associated with anorectal disorders

Dosage and Administration (34068-7)

Adults and Children 12 years and older: When practical, cleansethe affected area with mild soap and warm water and rinsethoroughly, Gently dry by patting or blotting with toitet tissue or aSoft cloth before application of this product. Apply externally to theaffected area up to 6 times daily.

Warnings and Precautions (34071-1)

Do not this product if pregnant or breastfeeding, ask a heaith professional before use

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN SECTION

Section 50566-9 (50566-9)

Stop use and ask a doctor if Condition worsens, or does notimprove within 7 days.Certain persons can develop aliergicreactions to ingredients in this product. if the symptom beingtreated does not subside or if redness, irritation, swelling, pain, orother symptoms develop or increase, discontinue use.

Section 50567-7 (50567-7)



CORRECT USE STEPS BEFORE TATTOOING

1.Clean hands and treatment area with mild soap and warmwater (to open pores to help absorb numbing cream), thengently dry.

2. Apply a thick layer of about 2mm to the treated area. (Makesure the tattoo area and surroundings are white cream)

3. Wrap tightly with plastic wrap, wait 60 minutes (longer fimebetter effect). lt is recommended to massage or tap iightlyevery 10 minutes to help the absorption of the numbing cream.

4.Wipe away residue, wait another 20-30 minutes for thenumbness to peak. And begin procedure.

Section 50570-1 (50570-1)



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

Do nat put into the reclum by using fingers or any medicatd evice or applicator.

Children under 12 years of age, consult a doctor.

Section 51727-6 (51727-6)

Aloe barbadensis 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 4%


Advanced Ingredient Data


Raw Label Data

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