Label: NO MORE PRODUCTS- glycerin, kaolin, calamine, menthol cream

  • NDC Code(s): 71831-005-01, 71831-005-02, 71831-005-03
  • Packager: PRANICURA GROUP LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients

    Glycerin      25%
    Kaolin        12.5%
    Calamine   12.5%
    Menthol        1%

  • PURPOSE

    Purposes

    Glycerin ....................................................Protectant
    Kaolin .........................................Protectant/Anti-Itch
    Calamine ....................................Protectant/Anti-Itch
    Menthol .....................................................Analgesic

  • INDICATIONS & USAGE

    Uses • Helps relieve the itching and discomfort associated with anorectal disorders •
    Provides temporary relief from the symptoms of perianal skin irritation • For the temporary
    relief of itching associated with moist anorectal conditions • For the temporary relief of
    irritation and burning

  • WARNINGS

    Warnings
    For rectal use only
    Do not use unless a prior doctor’s diagnosis of anorectal condition has been made
    When using this product do not exceed the recommended daily dosage unless directed by a doctor
    Stop use and ask a doctor if • bleeding occurs • condition worsens or does not improve within 7 days
    • allergic reaction develops • symptoms being treated do not subside or if redness, irritation, swelling, pain,
    other symptoms develop or increase • Do not put this product into the rectum by using fingers or any
    mechanical device or applicator. • Remove petrolatum or greasy ointment before using this product
    because they interfere with the ability of this product to adhere properly to the skin area.
    If pregnant or breastfeeding, 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 right away

  • DOSAGE & ADMINISTRATION

    Directions
    Adults: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.
    Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
    Apply a pea size amount of cream externally to the anal area and to the inner rim of the anus,
    not deep into the rectum. • Children under 12 years of age: consult a doctor • Apply externally to the
    affected area once or twice daily when pain or irritation is present.

  • OTHER SAFETY INFORMATION

    Other Information: Do not use if tube seal is cut, broken or missing. • store at 15-30º C (59-86º F)

  • INACTIVE INGREDIENT

    Inactive Ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetearyl Alcohol, Deionized Water,
    Dimethicone/Vinyl Dimethicone Crosspolymer, Isopropyl Palmitate, Magnesium Aluminum Silicate,
    Phenoxyethanol, Polysorbate 20, Propylene Glycol, SD Alcohol, Silica, Stearyl Alcohol

  • QUESTIONS

    Questions or Comments? Email: Admin@NoMoreProducts.com

  • No More Product Labeling

    No More Products

    Net Wt. 1.25oz (35g)

    Manufactured by Sarati Intn'i, 27502 Ted Hunt Rd., Los Fresnos TX  78566

    www.nomoreproducts.com

    No More Fissure Box

    NoMore -005 Box

    No More Fissure Tube

    NoMore -005 Tube

    No More Hemorrhoids Box

    NoMore Hemoroid Box 005-02

    No More Hemorrhoids Tube

    NoMore Hemoroid Tube 005-02

    No More Pruritus Box

    NoMore PruritusBox 005-01

    No More Pruritus Tube

    NoMore PruritusTube 005-01

    RES

  • INGREDIENTS AND APPEARANCE
    NO MORE PRODUCTS 
    glycerin, kaolin, calamine, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71831-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN25.0 g  in 100 g
    KAOLIN (UNII: 24H4NWX5CO) (KAOLIN - UNII:24H4NWX5CO) KAOLIN12.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION12.5 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71831-005-031 in 1 BOX03/01/2023
    135 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:71831-005-021 in 1 BOX03/01/2023
    235 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:71831-005-011 in 1 BOX03/01/2023
    335 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01503/01/2023
    Labeler - PRANICURA GROUP LLC (118320102)