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

----------

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

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 – 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

Principal Display Panel – Kit Label
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
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 DEA Schedule     
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
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 DEA Schedule     
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
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 (789573201)
Establishment
Name Address ID/FEI Business Operations
Coty US LLC 039056361 MANUFACTURE(66184-155)

Revised: 3/2013
Document Id: 016f9092-f2ba-44f7-81dd-a1f4fd694fea
Set id: a5d1bc0b-8b07-43ff-864d-d29a63ac5723
Version: 1
Effective Time: 20130326
 
Coty US LLC