LEADER MAXIMUM STRENGTH HEMORRHOIDAL RELIEF- lidocaine cream

Leader Maximum Strength Hemorrhoidal Relief by

Drug Labeling and Warnings

Leader Maximum Strength Hemorrhoidal Relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

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

Warnings

For external use only.

When using this product

• avoid contact with the eyes
• do not exceed the recommended daily dosage unless directed by a doctor
• do not put 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 breastfeeding

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• 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 of age: consult a doctor
• To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.

Other information

store at room temperature 68° - 77° F (20° - 25° C)

Inactive ingredients

aloe vera oil, benzyl alcohol, carbomer homopolymer, cholesterol, isopropyl myristate, mineral oil, polysorbate 80, propylene glycol, purifed water, sodium hydroxide, vitamin E

Questions?

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Package Labeling:

INGREDIENTS AND APPEARANCE

LEADER MAXIMUM STRENGTH HEMORRHOIDAL RELIEF 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0650
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0650-1	1 in 1 CARTON	02/01/2024
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	02/01/2024

Labeler - Cardinal Health,Inc. (063997360)