SALLY HANSEN MICROWAVABLE EYBROW, FACE AND LIP WAX KIT- benzocaine kit

Sally Hansen Microwavable Eybrow, Face and Lip Wax Kit by

Drug Labeling and Warnings

Sally Hansen Microwavable Eybrow, Face and Lip Wax Kit by is a Otc medication manufactured, distributed, or labeled by Coty US LLC, Crystal Claire Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

5% Benzocaine

Purpose

Topical analgesic

Uses

for temporary relief of pain and itching associated with minor skin irritations due to hair removal

Warnings

Allergy Alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

For external use only

When using this product

• avoid contact with eyes

Stop use and ask a doctor if

• condition worsens
• symptoms last for more than 7 days or clear up and occur again within a few days

Do not use in

• large quantities, over raws surfaces, or blistered areas

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• shake well
• use no more than 3 to 4 times daily

Adults and children 2 years of age and older apply to treated area immediately after hair removal

Children under 2 years of age consult a doctor

Inactive ingredients

Aqua/Water/Eau, Ethylhexyl Palmitate, Paraffinum Liquidum/ Mineral Oil/Huile Minerale, Propylene Glycol, Glyceryl Stearate, Cetyl Alcohol, Palmitic Acid, Triethanolamine, Stearic Acid, Imidazolidinyl Urea, Parfum/Fragrance, Peg-100 Stearate, Methylparaben, Carbomer, Tocopheryl Acetate, Lanolin Alcohol, Linalool, Benzyl Benzoate, Aloe Barbadensis Leaf Extract, Alcohol, Myristic Acid, Limonene, Geraniol, Citronellol, Eugenol, Citral, Soluble Collagen, Propylparaben, Citric Acid, Benzoic Acid, Tocopherol, BHT.

Questions or comments?

Call us at 1-800-953-5080 9:00AM - 5:00PM EST

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Kit Label

MICROWABLE
Eyebrow, Face & Lip
WAX KIT

WAX

Results last up
to 8 weeks!*
With mini tweezers
& brow guides

Topical analgesic with
5 % benzocaine

des resultants
jusqu'à 8 semaines !*
avec mini pince à épiler
et guides pour les sourcils

analgésique local avec
5 % de benzocaïne

*Individual results may vary
*les resultants individuals prevent varier

Wax / cire NET WT. 1.25 oz 35 g, Extrasoothe™ Lotion / lotion 0.5 fl oz 14.7 ml,
Brow Guides / guides pour les sourcils, Temperature Indicator Applicator . applicateur avec indicateur
de temperature, Mini Tweezers / mini pince à épiler, Orange Stick / bâtonnet orange, Instuctions

INGREDIENTS AND APPEARANCE

SALLY HANSEN MICROWAVABLE EYBROW, FACE AND LIP WAX KIT 
benzocaine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66184-155

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66184-155-01	1 in 1 CARTON	01/01/2012

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	0.05 g
Part 2	1 JAR	189.9 g

Part 1 of 2

SALLY HANSEN MICROWAVABLE EYBROW, FACE AND LIP WAX KIT 
benzocaine lotion

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
PALMITIC ACID (UNII: 2V16EO95H1)
TROLAMINE (UNII: 9O3K93S3TK)
STEARIC ACID (UNII: 4ELV7Z65AP)
IMIDUREA (UNII: M629807ATL)
PEG-100 STEARATE (UNII: YD01N1999R)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BENZYL BENZOATE (UNII: N863NB338G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALCOHOL (UNII: 3K9958V90M)
MYRISTIC ACID (UNII: 0I3V7S25AW)
GERANIOL (UNII: L837108USY)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
EUGENOL (UNII: 3T8H1794QW)
CITRAL (UNII: T7EU0O9VPP)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BENZOIC ACID (UNII: 8SKN0B0MIM)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.05 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	01/01/2012

Part 2 of 2

SALLY HANSEN MICROWAVABLE EYBROW, FACE AND LIP WAX KIT 
depilatories strip

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WHITE WAX (UNII: 7G1J5DA97F)
INGR	CALCIUM CARBONATE (UNII: H0G9379FGK)
INGR	MAGNESIUM CARBONATE (UNII: 0E53J927NA)
INGR	MINERAL OIL (UNII: T5L8T28FGP)
INGR	CANOLA OIL (UNII: 331KBJ17RK)
INGR	COCONUT OIL (UNII: Q9L0O73W7L)
INGR	APRICOT KERNEL OIL (UNII: 54JB35T06A)
INGR	CHAMOMILE (UNII: FGL3685T2X)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	D&C RED NO. 17 (UNII: ND733RX3JN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		189.9 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		01/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	01/01/2012

Labeler - Coty US LLC (039056361)