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Anorectal Cream

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

Medically reviewed by Drugs.com. Last updated on Nov 22, 2021.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients (in each gram)

Petrolatum 80%

Zinc Oxide 20%

Purpose

Anorectal Cream

Anorectal Cream

Uses

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.

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 or after each bowel movement

Other information

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

Package/Label Principal Display Panel

ANORECTAL
zinc oxide, petrolatum cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-088
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM) PETROLATUM 800 mg in 1 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 200 mg in 1 g
Packaging
# Item Code Package Description
1 NDC:53329-088-14 1 TUBE in 1 BOX
1 56.6 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part346 03/01/2010
Labeler - Medline Industries, Inc. (025460908)
Establishment
Name Address ID/FEI Operations
Ultra Seal Corporation 085752004 manufacture(53329-088)
Medline Industries, Inc.

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