Label: GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE cream

  • NDC Code(s): 55629-051-04
  • Packager: ONE2ZEE LIMITED LIABILITY COMPANY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 February 8, 2021

If you are a consumer or patient please visit this version.

  • DRUG FACTS:

  • Active Ingredient:

    Glycerin 14.4%
    Lidocaine 5%
    Phenylephrine HCl 0.25%
    White petrolatum 15%

  • Purpose

    • Protectant
    • Local anesthetic
    • Vasoconstrictor
    • Protectant
  • 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 help make bowel movements less painful
  • Warnings:

    • Ask a doctor before use if you have
    • Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.
  • 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 this cream.
    • Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
    • Children under 12 years of age: ask a doctor
  • 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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • Inactive Ingredients:

    aloe vera leaf, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, dexpanthenol, edetate disodium, glyceryl monosterate, methylparaben, mineral oil, laureth-23, steareth-2, steareth-20, propyl gallate, propylene glycol, propylparaben, sodium benzoate, tocopherol, alpha.- tocopherol acetate, xanthan gum, water

  • Other Information:

    Store at 20-25°C (68-77°F) Do not use if tamper evident packaging has been breached or is missing.

    Distributed by: Wellspring Airmont, NY 10952 U.S.A.

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE 
    glycerin, lidocaine, petrolatum, and phenylephrine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55629-051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN144 mg  in 1 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM150 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE2.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    LAURETH-23 (UNII: N72LMW566G)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55629-051-041 in 1 CARTON02/08/2021
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34602/08/2021
    Labeler - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
    Registrant - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
    Establishment
    NameAddressID/FEIBusiness Operations
    YASH PHARMACEUTICALS871409551manufacture(55629-051) , analysis(55629-051)