HEMORRHOIDAL RELIEF CREAM- lidocaine cream

Hemorrhoidal Relief Cream by

Drug Labeling and Warnings

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

Drug Details [pdf]

INDICATIONS & USAGE

Uses

Temporarily relieves pain, itching and discomfort due to anorectal disorders.

WARNINGS

For External Use Only

Allergy Alert- Certain persons can develop allergic reactions to ingredients in this product.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

When using this product

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

Stop use and ask a doctor if

• retal bleeding occurs
• condition worsens or does not improve within 7 days
• allergic reaction occurs
• symptoms clear up and return within a few days
• redness, irritation, swelling, pain, or other symptoms begin or increase

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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION

Directions

• Adults: when practical, cleanse the affected area with mild soap and warm water. Rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
• Adults and children 12 years and older: apply externally to the affected area up to 4 times a day.
• Children under 12 years of age: consult a doctor.
  

INACTIVE INGREDIENT

Inactive ingredients: Aloe Barbadensis Leaf Juice Extract, Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Triethanolamine, vitamin E Acetate, Vitis Vinifera (Grape) Skin Extract

ACTIVE INGREDIENT

OTHER SAFETY INFORMATION

• Store at 20-25 0C (68-77 oF)
• to secure child-resistant cap: screw cap tightly. Then turn cap in opposite direction. If clicking sound is not heard, repeat procedure.

QUESTIONS

Questions & Comments? 516-444-5749

PURPOSE

Local Anesthetic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEMORRHOIDAL RELIEF CREAM 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0468
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GRAPE (UNII: 6X543N684K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0468-1	1 in 1 BOX	09/01/2019
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 final	part346	08/15/2019

Labeler - Cardinal Health (097537435)

Registrant - Melaleuca, Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca, Inc.		805617610	manufacture(70000-0468)