RECTICARE ADVANCED (LIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUM) CREAM [FERNDALE LABORATORIES, INC.]

RECTICARE ADVANCED (LIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUM) CREAM [FERNDALE LABORATORIES, INC.]
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NDC 0496-0978-15, 0496-0978-30
Set ID 209212a7-7b6e-4b26-9f31-0eeb76f026bf
Category HUMAN OTC DRUG LABEL
Packager Ferndale Laboratories, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist, Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART346
  • 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

    Side1Side2

  • INGREDIENTS AND APPEARANCE
    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 AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL170 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE2.5 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM390 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETETH-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0496-0978-1515 g in 1 TUBE; Type 0: Not a Combination Product04/01/2016
    2NDC:0496-0978-3030 g in 1 TUBE; Type 0: Not a Combination Product08/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34604/01/2016
    Labeler - Ferndale Laboratories, Inc. (005320536)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ferndale Laboratories, Inc.005320536manufacture(0496-0978)

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