Your browser does not support JavaScript! SALLY HANSEN OUCH-RELIEF WAX STRIP KIT (BENZOCAINE) KIT [COTY US LLC]
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SALLY HANSEN OUCH-RELIEF WAX STRIP KIT (benzocaine) kit
[Coty US LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

Drug Facts

Active ingredient

6% 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. Not intended for use by children under 13 years of age

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

  • over raw surfaces, or blistered areas

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Rub well (see enclosed instructions)
  • Use wipes no more than 3 to 4 times daily.

Discard wipe after use.

Adults and children 13 years of age and older apply to the area to be treated 10 minutes before hair removal

Children under 13 years of age consult a doctor

Other information

As with all products containing benzocaine, localized allergic reactions may occur after prolonged or repeated use.

Inactive ingredients

ALCOHOL DENAT., AQUA/WATER/EAU, PROPYLENE GLYCOL, METHYLPARABEN

Questions or comments?

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

Principal Display Panel – Kit Label

OUCH-RELIEF™
WAX STRIP KIT

PAIN-
RELIEF
TECHNOLOGY™

FOR BODY
Pre-Treatment
for Pain-Free
Hair Removal

Results Last
up to
8 Weeks!*

Ready &
Easy to Use

*Individual hair re-growth results may vary

Body
Contouring
Strip

32 Wax Strips

Total 16 double-sided, 4 Benzocaine wipes, Azulene Finishing Oil 0.5 fl oz 14.7 ml, Instructions

Dermatologist & Salon Tested

Principal Display Panel – Kit Label
SALLY HANSEN OUCH-RELIEF   WAX STRIP KIT
benzocaine kit
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:66184-154
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66184-154-011 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET
Part 21 PACKET 32 
Part 1 of 2
OUCH-RELIEF WAX STRIP KIT 
benzocaine cloth
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine) Benzocaine0.0543 g
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Water 
Denatonium Benzoate 
Propylene Glycol 
Methylparaben 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
15 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/01/2012
Part 2 of 2
OUCH-RELIEF WAX STRIP KIT 
depilatories strip
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRRosin 
INGRMineral Oil 
INGRHigh Density Polyethylene 
INGRCastor Oil 
INGRSunflower Oil 
INGRIsopropyl Myristate 
INGRLINALOOL, (+/-)- 
INGR.ALPHA.-HEXYLCINNAMALDEHYDE 
INGRPENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) 
INGRISOMETHYL-.ALPHA.-IONONE 
INGRCYMBIDIUM HOOKERIANUM FLOWER 
INGRAlmond Oil 
INGRRosemary 
INGRBUTYLATED HYDROXYTOLUENE 
INGRFD&C YELLOW NO. 6 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
132 in 1 PACKET
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(66184-154)

Revised: 3/2013
 
Coty US LLC

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