ANORECTAL- zinc oxide, petrolatum cream

Anorectal by

Drug Labeling and Warnings

Anorectal by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ANORECTAL 
zinc oxide, petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-088
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	800 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-088-14	1 in 1 BOX	03/01/2010
1		56.6 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	03/01/2010

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	manufacture(53329-088)