Label: SALLY HANSEN ZERO BUMP BIKINI- pramoxine hydrochloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 October 19, 2021

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  • Drug Facts

    Active IngredientPurpose
    Pamoxine Hcl 1%Topical Analgesic

  • Purpose

    Topical Analgesic

  • Stop use and ask a doctor if

    • Condition gets worse
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again with a few days
  • Warnings

    • ​For external use only
    • When using this product avoid contact with the eyes
  • Keep out of reach of children

    If swallowed, get medical help or contact a poison control center right away.

  • Directions

    • Adults and children 2 years of age and older apply product to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age consult a doctor
    • Use after shaving, waxing or after using hair removal creams. Will not stain lingerie, swimwear or clothing.
  • Inactive ingredients

    AQUA/WATER/EAU, HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER,
    ALCOHOL, GLYCERIN, BUTYLENE GLYCOL, SODIUM CITRATE, PHENOXYETHANOL, LACTIC ACID,
    PARFUM/FRAGRANCE, PEG-12 DIMETHICONE, ETHYLHEXYLGLYCERIN, TETRASODIUM EDTA, BENZYL
    BENZOATE, PROPYLENE GLYCOL, CITRUS AURANTIUM DULCIS (ORANGE) FLOWER EXTRACT, ORCHIS
    MASCULA FLOWER EXTRACT, PASSIFLORA INCARNATA EXTRACT, ALOE BARBADENSIS LEAF EXTRACT,
    SODIUM HYDROXIDE, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, TOCOPHEROL, IMIDAZOLIDINYL UREA,
    METHYLPARABEN, DIAZOLIDINYL UREA, PROPYLPARABEN, BUTYLPARABEN, ETHYLPARABEN,
    ISOBUTYLPARABEN, CITRIC ACID

  • Uses

    For temporary relief of pain and itching associated with minor cuts or minor skin irritation due to hair removal.

  • DOSAGE & ADMINISTRATION

  • Label

    coty 2coty 1

  • INGREDIENTS AND APPEARANCE
    SALLY HANSEN ZERO BUMP BIKINI 
    pramoxine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66184-160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HAMAMELIS VIRGINIANA FLOWER WATER (UNII: 222MYC9QUV)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ORCHIS MASCULA FLOWER (UNII: 6H1JQK35LA)  
    PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    N-(3,4-BIS(HYDROXYMETHYL)-2,5-DIOXO-4-IMIDAZOLIDINYL)-N,N'-BIS(HYDROXYMETHYL)UREA (UNII: 483JN0JNJA)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LACTIC ACID, DL- (UNII: 3B8D35Y7S4)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .BETA.-TOCOPHEROL (UNII: 9U6A490501)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66184-160-021 in 1 BLISTER PACK01/01/2015
    1NDC:66184-160-0125 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2015
    Labeler - Coty US LLC (039056361)
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