Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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SALLY HANSEN OUCH-RELIEF STRIPLESS HARD 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

(Ouch-Relief™ Numbing Wipe)

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 Stripless Hard Wax Kit Label

OUCH-RELIEF™
STRIPLESS HARD WAX KIT

PAIN-
RELIEF
TECHNOLOGY™

Sally Hansen ®

FOR FACE & BODY

Pre-Treatment Helps
Reduce Pain While
Waxing

Results Last Up to
8 Weeks!*

Body Contouring
Formula Eliminates
Coarse Hair

*Individual hair re-growth results may vary

Wax NET WT. 4.0 oz 113 g,

3 Ouch-Relief™ Numbing Wipes,
6 Spatulas, 4 Azulene Oil Finish Wipes,
Instructions

Dermatologist & Salon Tested

Principal Display Panel - Sally Hansen Ouch-Relief Stripless Hard Wax Kit Label
SALLY HANSEN OUCH-RELIEF STRIPLESS HARD WAX KIT 
benzocaine kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 66184-161
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 66184-161-011 in 1 CARTON; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 13 APPLICATOR
Part 21 PACKET
Part 31 JAR 113.4 g
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 OIL FINISHING WIPE 
other skin care preparations
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRMINERAL OIL (UNII: T5L8T28FGP)  
INGRISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
INGRWHEAT GERM OIL (UNII: 14C97E680P)  
INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
INGRGUAIAZULENE (UNII: 2OZ1K9JKQC)  
INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 PACKET; 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 
other skin care preparations
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRGLYCERYL ROSINATE (UNII: SD112V492J)  
INGRPARAFFIN (UNII: I9O0E3H2ZE)  
INGRYELLOW WAX (UNII: 2ZA36H0S2V)  
INGRPOLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRMICA (UNII: V8A1AW0880)  
INGROAT KERNEL OIL (UNII: 3UVP41R77R)  
INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
INGR.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
INGRGERANIOL (UNII: L837108USY)  
INGR.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
INGRBENZYL BENZOATE (UNII: N863NB338G)  
INGRISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRPENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
INGRTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1113.4 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
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


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