Walgreens Anorectal Lidocaine Cream

Walgreens Anorectal Lidocaine Cream
SPL v2
SPL
SPL Set ID 995fffc0-3203-0810-e053-2995a90ae276
Route
TOPICAL
Published
Effective Date 2020-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Hydrogenated Soybean Lecithin Water Benzyl Alcohol Carbomer 940 Isopropyl Myristate Polysorbate 80 Propylene Glycol Trolamine .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-01-15

Description

Lidocaine HCl 5%


Medication Information

Warnings and Precautions

For external use only

When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor, do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if rectal bleeding occurs, condition worsens or does not improve within 7 days, allergic reaction occurs to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, symptoms clear up and return within a few days.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Dosage and Administration

When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.

Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.

Children under 12 years: consult a doctor

To use finger cots: Roll one finger cot over finger. Gently squeeze cream over affected area.

Description

Lidocaine HCl 5%

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

benzyl alcohol, carbomer, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, triethanolamine, vitamin E, purified water.

Section 51945-4

Section 55105-1

Local anesthetic

Section 55106-9

Lidocaine HCl 5%

Section 60561-8

Store at room temperature (20-25 C) (68-77 F). Avoid excessive heat and cold. Protect from sunlight.


Structured Label Content

Indications and Usage (34067-9)

helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Dosage and Administration (34068-7)

When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.

Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.

Children under 12 years: consult a doctor

To use finger cots: Roll one finger cot over finger. Gently squeeze cream over affected area.

Warnings and Precautions (34071-1)

For external use only

When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor, do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if rectal bleeding occurs, condition worsens or does not improve within 7 days, allergic reaction occurs to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, symptoms clear up and return within a few days.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

benzyl alcohol, carbomer, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, triethanolamine, vitamin E, purified water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Local anesthetic

Section 55106-9 (55106-9)

Lidocaine HCl 5%

Section 60561-8 (60561-8)

Store at room temperature (20-25 C) (68-77 F). Avoid excessive heat and cold. Protect from sunlight.


Advanced Ingredient Data


Raw Label Data

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