Label: SIGNATURE CARE HEMORRHOIDAL CREAM (WITH APPLICATOR)- phenylephrine hydrochloride, pramoxine hydrochloride, glycerin, petrolatum cream

  • NDC Code(s): 21130-981-02
  • Packager: BETTER LIVING BRANDS, LLC
  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated January 4, 2021

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  • ACTIVE INGREDIENT

    Active ingredients Purpose

    Glycerin 14.4%............................................................Skin protectant

    Phenylephrine HCl 0.25%...........................................Vasconstrictor

    Pramoxine HCl 1%......................................................Local anesthetic

    White petrolatum 15%.................................................Skin protectant

  • PURPOSE

    Uses

    • for temporary relief of pain, soreness and burning
    • helps relieve the local itching and discomfort associated with hemorrhoids
    • temporarily shrinks hemorrhoidal tissue
    • temporarily provides a coating for relief of anorectal discomforts
    • temporarily protects the inflamed, irritated anorectal surface to make bowel movements less painful
  • WARNINGS

    Warnings

    For external and/or intrarectal use only

  • ASK DOCTOR

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • difficult in urination due to enlargement of the prostate gland
    • diabetes
  • WHEN USING

    When using this product

    • do not exceed the recommended daily dosage unless directed by a doctor
    • do not put into the rectum by using fingers or any mechanical device or applicator
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens or does not improve within 7 days
    • bleeding occurs
    • an allergic reaction develops
    • the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional 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 (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream.
    • when first opening the tube, peel back foil seal
    • apply externally or in the lower portion of the anal canal only
    • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
    • for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus
    • thoroughly cleanse dispensing cap after each use and replace cover
    • children under 12 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store at room temperature 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    .alpha.-tocopherol acetate, aloe vera leaf, anhydrous lanolin, butylated hydroxytoluene, cetostearyl alcohol, cetyl esters wax, cetyl palmitate, glycryl monostearate, isopropyl myristate, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, steareth-20, stearic acid, trisodium citrate dihydrate

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Better Living Brands LLC

    Made in China

  • PRINCIPAL DISPLAY PANEL

    78981.1

  • INGREDIENTS AND APPEARANCE
    SIGNATURE CARE HEMORRHOIDAL CREAM (WITH APPLICATOR) 
    phenylephrine hydrochloride, pramoxine hydrochloride, glycerin, petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-981
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN144 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM150 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    STEARETH-20 (UNII: L0Q8IK9E08)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    WATER (UNII: 059QF0KO0R)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LANOLIN (UNII: 7EV65EAW6H)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-981-021 in 1 CARTON01/04/2021
    157 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/04/2021
    Labeler - BETTER LIVING BRANDS, LLC (009137209)
    Registrant - United Exchange Corp. (840130579)