zero bumps bikini spray

zero bumps bikini spray

Drug Labeling and Warnings

Drug Details

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SALLY HANSEN ZERO BUMP BIKINI- pramoxine hydrochloride spray 
Coty US LLC

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.

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zero bumps bikini spray

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.

Label

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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)

Revised: 5/2019
 
Coty US LLC


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