ANORECTAL- petrolatum and zinc oxide cream 
Medline Industries, Inc.

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.

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Drug Facts

Active ingredients (in each gram)

Petrolatum 80%

Zinc Oxide 20%

Purpose

Protectant

Protectant

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

Protect from freezing. Avoid excessive heat.

Do not use if packet is torn, cut or opened.

Package/Label Principal Display Panel

Curad Zinc Oxide Anorectal Cream

Curad Zinc Oxide Anorectal Cream

CURAD

WE HELP HEAL

ZINC OXIDE

anorectal cream

latex free

NET WT. 2 oz (56.6 g)

ANORECTAL 
zinc oxide, petrolatum cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53329-088
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM800 mg  in 1 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE200 mg  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-088-141 in 1 BOX
156.6 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/01/2010
Labeler - Medline Industries, Inc. (025460908)

Revised: 7/2010
Document Id: da9f9e5b-1914-494d-b9de-3e2a14c2fba6
Set id: da9f9e5b-1914-494d-b9de-3e2a14c2fba6
Version: 1
Effective Time: 20100728
 
Medline Industries, Inc.