SIMPLY VITAL HEMORRHOID AND ANORECTAL RELIEF- lidocaine cream

SIMPLY VITAL HEMORRHOID and ANORECTAL RELIEF by

Drug Labeling and Warnings

SIMPLY VITAL HEMORRHOID and ANORECTAL RELIEF by is a Otc medication manufactured, distributed, or labeled by ALPHA PLANTS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Lidocaine 5.00 %

Purpose

Anorectal (hemorrhoidal)

Uses:

• For the temporary relief of itching and discomfort in the perianal area.
• For the temporary relief of pain, soreness, or burning.

Warnings:

For external use only.

Do not

• Put this product into the rectum by using fingers or any mechanical device or applicator.
• Exceed the recommended daily dosage unless directed by a doctor.

When using this product

• If condition worsens or does not improve within 7 days, consult a doctor.
• In case of bleeding, consult a doctor promptly.

Discontinue use and consult a doctor if

• The symptoms being treated does not subside.
• Redness, irritation, swelling, pain, or other symptoms develop or increase.

• Certain persions can develop allergic reactions to ingredients in this product.

Allergy alert

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use.

Directions:

Adults: 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 a soft cloth before application of this product.

Children under 12 years of age: consult a doctor.

Apply to the affected area up to 6 times daily.

Other information:

• Store at 20-25°C (68-77°F) and protect from moisture.

Inactive ingredients:

Allantoin, Deionized Water, Benzyl Alcohol, Carbomer, Propylene Glycol, SD Alcohol 40-B, Sodium Polyacrylate, Tocopheryl Acetate (Vitamin E).

Questions?

+1 (205) 624-9177

Package Labeling:

INGREDIENTS AND APPEARANCE

SIMPLY VITAL HEMORRHOID AND ANORECTAL RELIEF 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82460-262
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 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82460-262-00	30 mL in 1 TUBE; Type 0: Not a Combination Product	01/09/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	01/09/2022

Labeler - ALPHA PLANTS INC (118246522)