SIMPLY VITAL HEMORRHOID AND ANORECTAL RELIEF- lidocaine cream 
ALPHA PLANTS INC

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SIMPLY VITAL HEMORRHOID & ANORECTAL RELIEF

Drug Facts

Active ingredient

Lidocaine 5.00 %

Purpose

Anorectal (hemorrhoidal)

Uses:

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:

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:

Label

SIMPLY VITAL HEMORRHOID AND ANORECTAL RELIEF 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82460-262
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82460-262-0030 mL in 1 TUBE; Type 0: Not a Combination Product01/09/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01501/09/2022
Labeler - ALPHA PLANTS INC (118246522)

Revised: 11/2023
Document Id: 09e2e2ce-d887-0711-e063-6294a90a9213
Set id: 79fa4b89-382f-45fa-a792-90a9fe5bf573
Version: 2
Effective Time: 20231111
 
ALPHA PLANTS INC