Label: SALLY HANSEN OUCH-RELIEF WAX STRIP KIT- benzocaine kit
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Contains inactivated NDC Code(s)
NDC Code(s): 66184-162-01, 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 October 19, 2021
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 Wax Strip Kit Label
OUCH-RELIEF™
WAX STRIP KITWAX
PAIN-
RELIEF
TECHNOLOGY™Sally Hansen ®
FOR FACE
& BIKINIPre-Treatment
for Pain-Free
Hair RemovalResults Last
Up to
8 Weeks!*Ready &
Easy to Use*Individual hair
re-growth results
may varyContouring
Strip24 Wax
Strips2
SizesTotal 12 double sided, 3 Benzocaine wipes,
Azulene Finishing Oil 0.5 fl oz 14.7 ml, InstructionsDermatologist & Salon Tested
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INGREDIENTS AND APPEARANCE
SALLY HANSEN OUCH-RELIEF WAX STRIP KIT
benzocaine kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66184-162 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66184-162-01 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 JAR 14.17 g Part 3 2 PACKET 24 Part 1 of 3 OUCH-RELIEF NUMBING WIPE
benzocaine clothProduct Information Item Code (Source) NDC:66184-163 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 FINISHING OIL INGREDIENTS
other skin care preparations oilProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4) INGR SESAME OIL (UNII: QX10HYY4QV) INGR C13-14 ISOPARAFFIN (UNII: E4F12ROE70) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR ETHYLPARABEN (UNII: 14255EXE39) INGR GUAIAZULENE (UNII: 2OZ1K9JKQC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 14.17 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 Part 3 of 3 WAX STRIP
other skin care preparations stripProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR ROSIN (UNII: 88S87KL877) INGR GLYCERYL ROSINATE (UNII: SD112V492J) INGR MINERAL OIL (UNII: T5L8T28FGP) INGR HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 12 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 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)