Label: SALLY HANSEN ZERO BUMP BIKINI- pramoxine hydrochloride spray
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Contains inactivated NDC Code(s)
NDC Code(s): 66184-160-01, 66184-160-02 - Packager: Coty US LLC
- 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Stop use and ask a doctor if
- Warnings
- Keep out of reach of children
- Directions
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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
- DOSAGE & ADMINISTRATION
- Label
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INGREDIENTS AND APPEARANCE
SALLY HANSEN ZERO BUMP BIKINI
pramoxine hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66184-160 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:66184-160-02 1 in 1 BLISTER PACK 01/01/2015 1 NDC:66184-160-01 25 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2015 Labeler - Coty US LLC (039056361)