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.

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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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:66184-155
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66184-155-011 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 0.05 g
Part 21 JAR 189.9 g
Part 1 of 2
SALLY HANSEN MICROWAVABLE EYBROW, FACE AND LIP WAX KIT 
benzocaine lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine) Benzocaine0.05 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
water 
ethylhexyl palmitate 
mineral oil 
propylene glycol 
glyceryl monostearate 
cetyl alcohol 
palmitic acid 
trolamine 
stearic acid 
imidurea 
peg-100 stearate 
methylparaben 
.ALPHA.-TOCOPHEROL ACETATE 
lanolin alcohols 
LINALOOL, (+/-)- 
Benzyl Benzoate 
aloe vera leaf 
alcohol 
myristic acid 
geraniol 
.BETA.-CITRONELLOL, (R)- 
eugenol 
citral 
propylparaben 
citric acid monohydrate 
Benzoic Acid 
tocopherol 
butylated hydroxytoluene 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.05 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/01/2012
Part 2 of 2
SALLY HANSEN MICROWAVABLE EYBROW, FACE AND LIP WAX KIT 
depilatories strip
Product Information
Route of AdministrationTOPICALDEA Schedule    
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRwhite wax 
INGRcalcium carbonate 
INGRmagnesium carbonate 
INGRmineral oil 
INGRcanola oil 
INGRcoconut oil 
INGRapricot kernel oil 
INGRchamomile 
INGRaloe vera leaf 
INGRD&C Red No. 17 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1189.9 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/01/2012
Labeler - Coty US LLC (789573201)
Establishment
NameAddressID/FEIBusiness Operations
Coty US LLC039056361MANUFACTURE(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