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Recticare Advanced by Ferndale Laboratories, Inc.

Medically reviewed on March 19, 2018.

Dosage form: cream
Ingredients: LIDOCAINE 50mg in 1g, MINERAL OIL 170mg in 1g, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 1g, PETROLATUM 390mg in 1g
Labeler: Ferndale Laboratories, Inc.
NDC Code: 0496-0978

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.

Recticare Advanced Hemorrhoidal Cream

Active ingredients

Lidocaine 5% w/w
Mineral Oil 17% w/w
Phenylephrine HCl 0.25% w/w
White Petrolatum 39% w/w

Purpose

Lidocaine 5% w/w....................................Local anesthetic
Mineral Oil 17% w/w................................Protectant
Phenylephrine HCl 0.25% w/w.................Vasoconstrictor
White Petrolatum 39% w/w.....................Protectant

Uses
  • helps relieve the pain, itching and burning associated with hemorrhoids
  • temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects irritated areas and inflamed perianal skin

Warnings

For external use only.

Ask a doctor before use if you have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug for high blood pressure or depression

When using this product
  • avoid contact with eyes
  • do not exceed recommended daily dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if
  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

If pregnant or breastfeeding,

ask a doctor before use.

Keep out of reach of children.

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

Directions
  • 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 soft cloth before applying.
  • adults and children 12 years and older: apply externally to the affected area up to 4 times daily
  • children under 12 years of age: consult a doctor
  • To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.

Other information

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]

Inactive ingredients

ceteth 20, cetostearyl alcohol, citric acid, propylparaben, purified water

Package Label

RECTICARE ADVANCED 
lidocaine and mineral oil and phenylephrine hcl and white petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0496-0978
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE50 mg  in 1 g
MINERAL OIL (MINERAL OIL) MINERAL OIL170 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE2.5 mg  in 1 g
PETROLATUM (PETROLATUM) PETROLATUM390 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETETH-20 
CETOSTEARYL ALCOHOL 
ANHYDROUS CITRIC ACID 
PROPYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:0496-0978-1515 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/01/2016
Labeler - Ferndale Laboratories, Inc. (005320536)
Establishment
NameAddressID/FEIOperations
Ferndale Laboratories, Inc.005320536manufacture(0496-0978)

 
Ferndale Laboratories, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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