Drug Facts

Active Ingredient	Purpose
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

coty 2 coty 1

SALLY HANSEN ZERO BUMP BIKINI
pramoxine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66184-160
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/01/2015

Labeler - Coty US LLC (039056361)

zero bumps bikini spray