Lidocaine 5% New 6oz Ww

Lidocaine 5% New 6oz Ww
SPL v1
SPL
SPL Set ID 472fe0d1-31a1-fded-e063-6394a90a4a66
Route
TOPICAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
C10-18 Triglycerides Propylene Glycol Hydrogenated Soybean Lecithin Tocopherol Carbomer Homopolymer Type C Water Polysorbate 80 Trolamine Cholesterol Isopropyl Myristate Benzyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

Description

Lidocaine 5%

Purpose

Anorectal (hemorrhoidal) cream


Medication Information

Purpose

Anorectal (hemorrhoidal) cream

Description

Lidocaine 5%

Usages

Temporarily relieves the pain and itching due to anorectal disorders.

Section 50565-1

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center Right Away

Section 51945-4

Warnings

For external use only.



When using this product

avoid contact with eyes

do not exceed recommended dosage unlesss directed by a doctor

do not use in large quantaties, particularly over large surfaces or blistered areas

do not put this product into the rectum by using fingers or any medical devices or applicators



Stop and ask a doctor if



rectal bleeding occurs

condition worsens or does not improve within 7 days

allergic reaction occurs to ingredients in the product

symptoms being treated do not subsise or if redness, irritation, swelling, pain or other symptoms develop or increase

symptoms clear up and return within a few days

Flammable

keep away from fire or flame





If pregnant or breast feading, as a health professional before use.



Keep out of reach of children



If swallowed, get medical help or contact a Poison Control Center Right Away

Directions

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 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 of age: consult a doctor.

Active Ingredient

Lidocaine 5%

Inactive Ingrediants

benzyl alcohol, carbomer hompolymer type C, Cl 0-18 triglycerides, cholesterol, lecithin, isopropyl myristate,

polysorbate 80, propylene glycol, tocopherol, trolamine, water.


Structured Label Content

Usages

Temporarily relieves the pain and itching due to anorectal disorders.

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 51945-4 (51945-4)

Purpose

Anorectal (hemorrhoidal) cream

Warnings

For external use only.



When using this product

avoid contact with eyes

do not exceed recommended dosage unlesss directed by a doctor

do not use in large quantaties, particularly over large surfaces or blistered areas

do not put this product into the rectum by using fingers or any medical devices or applicators



Stop and ask a doctor if



rectal bleeding occurs

condition worsens or does not improve within 7 days

allergic reaction occurs to ingredients in the product

symptoms being treated do not subsise or if redness, irritation, swelling, pain or other symptoms develop or increase

symptoms clear up and return within a few days

Flammable

keep away from fire or flame





If pregnant or breast feading, as a health professional before use.



Keep out of reach of children



If swallowed, get medical help or contact a Poison Control Center Right Away

Directions

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 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 of age: consult a doctor.

Active Ingredient

Lidocaine 5%

Inactive Ingrediants

benzyl alcohol, carbomer hompolymer type C, Cl 0-18 triglycerides, cholesterol, lecithin, isopropyl myristate,

polysorbate 80, propylene glycol, tocopherol, trolamine, water.


Advanced Ingredient Data


Raw Label Data

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