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Anorectal Cream Prescribing Information

Package insert / product label
Generic name: petrolatum and zinc oxide
Dosage form: cream
Drug class: Miscellaneous topical agents

Medically reviewed by Drugs.com. Last updated on Feb 28, 2024.

Active ingredients (in each gram)

Petrolatum 80%

Zinc Oxide 20%

Purpose

Anorectal Cream

Anorectal Cream

Indications and Usage for Anorectal Cream

For the temporary relief of

  • Local itching and discomfort in the perianal area, associated with anorectal disorders
  • Temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues
  • Temporarily protects irritated areas
  • Temporarily relieves burning
  • Temporarily protects the inflamed irritated anorectal surfaces

Warnings

For external use only

  • condition worsens or does not improve within 7 days, consult a doctor
  • Do not exceed the recommended daily dosage unless directed by a doctor
  • In case of bleeding, consult a doctor promptly
  • Do not put this product into the rectum by using fingers or any mechanical device or applicator

KEEP OUT OF REACH OF CHILDREN.

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

Anorectal Cream Dosage and Administration

  • 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 or after each bowel movement

Storage and Handling

  • Store at controlled room temperature 68º-77ºF (20º-25ºC).
  • Use only if packaging is intact.

Package/Label Principal Display Panel

label

ANORECTAL
zinc oxide, petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-088
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM800 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-088-141 in 1 BOX03/01/2010
156.6 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/01/2010
Labeler - Medline Industries, Inc. (025460908)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004manufacture(53329-088)

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