SALLY HANSEN OUCH-RELIEF  WAX STRIP 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

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

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:66184-154
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66184-154-01 1 in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 PACKET
Part 2 1 PACKET 32 
Part 1 of 2
OUCH-RELIEF WAX STRIP KIT 
benzocaine cloth
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 0.0543 g
Inactive Ingredients
Ingredient Name Strength
Alcohol (UNII: 3K9958V90M)  
Water (UNII: 059QF0KO0R)  
Denatonium Benzoate (UNII: 4YK5Z54AT2)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Methylparaben (UNII: A2I8C7HI9T)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 PACKET
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
OUCH-RELIEF WAX STRIP KIT 
depilatories strip
Product Information
Other Ingredients
Ingredient Kind Ingredient Name Quantity
INGR Rosin (UNII: 88S87KL877)  
INGR Mineral Oil (UNII: T5L8T28FGP)  
INGR High Density Polyethylene (UNII: UG00KM4WR7)  
INGR Castor Oil (UNII: D5340Y2I9G)  
INGR Sunflower Oil (UNII: 3W1JG795YI)  
INGR Isopropyl Myristate (UNII: 0RE8K4LNJS)  
INGR LINALOOL, (+/-)- (UNII: D81QY6I88E)  
INGR .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
INGR PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
INGR ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
INGR CYMBIDIUM HOOKERIANUM FLOWER (UNII: H2DJ03DI5I)  
INGR Almond Oil (UNII: 66YXD4DKO9)  
INGR Rosemary (UNII: IJ67X351P9)  
INGR BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
INGR FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 32 in 1 PACKET
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(66184-154)

Revised: 3/2013
Document Id: 5dc5d42a-45ae-400d-8ddd-b80bd720436b
Set id: a29f5b9e-6f63-46fb-8417-64906aaf005b
Version: 1
Effective Time: 20130326
 
Coty US LLC