Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

k">

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.

----------

Drug Facts

(Benzocaine Wipes)

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 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

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 - Sally Hansen Ouch-Relief Wax Strip Kit Label

OUCH-RELIEF™
WAX STRIP KIT

WAX

PAIN-
RELIEF
TECHNOLOGY™

Sally Hansen ®

FOR FACE
& BIKINI

Pre-Treatment
for Pain-Free
Hair Removal

Results Last
Up to
8 Weeks!*

Ready &
Easy to Use

*Individual hair
re-growth results
may vary

Contouring
Strip

24 Wax
Strips

2
Sizes

Total 12 double sided, 3 Benzocaine wipes,
Azulene Finishing Oil 0.5 fl oz 14.7 ml, Instructions

Dermatologist & Salon Tested

Principal Display Panel - Sally Hansen Ouch-Relief Wax Strip Kit Label
SALLY HANSEN OUCH-RELIEF WAX STRIP KIT 
benzocaine kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 66184-162
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 66184-162-011 in 1 CARTON; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 13 APPLICATOR
Part 21 JAR 14.17 g
Part 32 PACKET 24 
Part 1 of 3
OUCH-RELIEF NUMBING WIPE 
benzocaine cloth
Product Information
Item Code (Source)NDC: 66184-163
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 66184-163-013 in 1 PACKET
11 in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34810/18/2018
Part 2 of 3
AZULENE FINISHING OIL INGREDIENTS 
other skin care preparations oil
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
INGRSESAME OIL (UNII: QX10HYY4QV)  
INGRC13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRMENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRETHYLPARABEN (UNII: 14255EXE39)  
INGRGUAIAZULENE (UNII: 2OZ1K9JKQC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
114.17 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic10/18/2018
Part 3 of 3
WAX STRIP 
other skin care preparations strip
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRROSIN (UNII: 88S87KL877)  
INGRGLYCERYL ROSINATE (UNII: SD112V492J)  
INGRMINERAL OIL (UNII: T5L8T28FGP)  
INGRHIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
112 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic10/18/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34810/18/2018
Labeler - Coty US LLC (039056361)

Revised: 5/2019
 
Coty US LLC


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.