Recticare Advanced Hemorrhoidal Cream

Recticare Advanced Hemorrhoidal Cream
SPL v6
SPL
SPL Set ID 209212a7-7b6e-4b26-9f31-0eeb76f026bf
Route
TOPICAL
Published
Effective Date 2020-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg) Mineral Oil (170 mg) Phenylephrine (2.5 mg) Petrolatum (390 mg)
Inactive Ingredients
Ceteth-20 Cetostearyl Alcohol Anhydrous Citric Acid Propylparaben Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-04-01

Description

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


Medication Information

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

Description

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

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.

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.
Package Label

Other Information

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

Active Ingredients

Lidocaine 5% w/w

Mineral Oil 17% w/w

Phenylephrine HCl 0.25% w/w

White Petrolatum 39% w/w

Inactive Ingredients

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

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.

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


Structured Label Content

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
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

Warnings

For external use only.

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.
Package Label

Other Information (Other information)

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

Active Ingredients (Active ingredients)

Lidocaine 5% w/w

Mineral Oil 17% w/w

Phenylephrine HCl 0.25% w/w

White Petrolatum 39% w/w

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (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 (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, (If pregnant or breastfeeding,)

ask a doctor before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

presently taking a prescription drug for high blood pressure or depression


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