Label: BOTTOMS UP HEALTH- lidocaine,glycerin,calamine,witch hazel cream

  • NDC Code(s): 70372-731-01
  • Packager: CENTURA PHARMACEUTICALS INC
  • 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 May 27, 2023

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

  • ACTIVE INGREDIENTS

    Calamine 15%

    Glycerin 35%

    Lidocaine 5%

    Witch Hazel 10%

  • PURPOSE

    Protectant, Protectant, Anesthetic, Protectant

  • USES

    Helps relieve the pain, burning, soreness and itching associated with inflamed hemorrhoidal tissue and other anorectal disorders.

    Temporarily protects inflamed and irritated anorectal surface to help make bowel movements less.

  • WARNINGS

    For external use only

  • STOP USE AND ASK A DOCTOR IF

    ■ the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase ■ condition worsens or does not improve within 7 days

  • ALLERGY ALERT

    Certain persons can develop allergic reactions to ingredients in this product.

  • OTHER WARNINGS

    Do not exceed the recommended dose unless directed by a doctor.

    In case of bleeding, consult a doctor promptly.

    Do not put this product into the rectum by using fingers or any mechanical device or applicator.

  • KEEP OUT OF REACH OF CHILDREN

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

  • IF PREGNANT OR BREAST FEEDING

    Ask a health professional before use.

  • DIRECTIONS

    Adults and children over 12 years old ■ Apply externally to affected area up to 6 times a day or after each bowel movement

    ■ Clean affected area with mild soap and warm water, rinse thoroughly and gently dry by patting or blotting with toilet tissue or a soft cloth before using this product.

    ■ Children under 12 years of age: consult a doctor.

  • OTHER INFORMATION

    Store at room temperature and away from direct sunlight.

  • INACTIVE INGREDIENTS

    Acrylates C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Amica Montana Flower Extract, Behentrimonium Methosulfate, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Cetearyl Alcohol, Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Glyceryl Stearate, lsopropyl Palmitate, Magnesium Aluminum Silicate, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polysorbate-20, Propylene Glycol, Silica.

  • QUESTIONS

    813-666-7867

  • PACKAGE LABELING

    PACKAGE LABELING

  • INGREDIENTS AND APPEARANCE
    BOTTOMS UP HEALTH 
    lidocaine,glycerin,calamine,witch hazel cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70372-731
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN35 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 g
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70372-731-0156 g in 1 JAR; Type 0: Not a Combination Product05/27/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01505/27/2023
    Labeler - CENTURA PHARMACEUTICALS INC (084921637)
    Registrant - CENTURA PHARMACEUTICALS INC (084921637)