Label: SALLY HANSEN OUCH-RELIEF STRIPLESS HARD WAX KIT- benzocaine kit
- NDC Code(s): 66184-161-01, 66184-163-01
- Packager: Coty US LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated July 5, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel - Sally Hansen Ouch-Relief Stripless Hard Wax Kit Label
OUCH-RELIEF™
STRIPLESS HARD WAX KITPAIN-
RELIEF
TECHNOLOGY™Sally Hansen ®
FOR FACE & BODY
Pre-Treatment Helps
Reduce Pain While
WaxingResults 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,
InstructionsDermatologist & Salon Tested
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INGREDIENTS AND APPEARANCE
SALLY HANSEN OUCH-RELIEF STRIPLESS HARD WAX KIT
benzocaine kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66184-161 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66184-161-01 1 in 1 CARTON; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 3 APPLICATOR 3 Part 2 1 PACKET 4 Part 3 1 JAR 113.4 g Part 1 of 3 OUCH-RELIEF NUMBING WIPE
benzocaine clothProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 6 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66184-163-01 3 in 1 PACKET 1 1 in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 10/18/2018 Part 2 of 3 AZULENE OIL FINISHING WIPE
other skin care preparationsProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR MINERAL OIL (UNII: T5L8T28FGP) INGR ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) INGR WHEAT GERM OIL (UNII: 14C97E680P) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) INGR GUAIAZULENE (UNII: 2OZ1K9JKQC) INGR ASCORBYL PALMITATE (UNII: QN83US2B0N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 10/18/2018 Part 3 of 3 WAX
other skin care preparationsProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR GLYCERYL ROSINATE (UNII: SD112V492J) INGR PARAFFIN (UNII: I9O0E3H2ZE) INGR YELLOW WAX (UNII: 2ZA36H0S2V) INGR POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR MICA (UNII: V8A1AW0880) INGR OAT KERNEL OIL (UNII: 3UVP41R77R) INGR COCONUT OIL (UNII: Q9L0O73W7L) INGR SUNFLOWER OIL (UNII: 3W1JG795YI) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) INGR GERANIOL (UNII: L837108USY) INGR .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) INGR BENZYL BENZOATE (UNII: N863NB338G) INGR ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) INGR TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 113.4 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 10/18/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 10/18/2018 Labeler - Coty US LLC (039056361) Establishment Name Address ID/FEI Business Operations Crystal Claire Cosmetics Inc. 205493484 manufacture(66184-161)