FDA.reportPublic FDA data

Sally Hansen Ouch-Relief Wax Strip Kit

Manufacturer
Coty US LLC
Effective date
2021-10-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:44:19

Label at a glance#

ProductSally Hansen Ouch-Relief Wax Strip Kit
Active ingredientBENZOCAINE
Label structure10 sections

Indications and uses

for temporary relief of pain and itching associated with minor skin irritations due to hair removal

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

(Benzocaine Wipes)

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

6% Benzocaine

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

for temporary relief of pain and itching associated with minor skin irritations due to hair removal

Warnings

WARNINGS SECTION

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

OTC - WHEN USING SECTION

  • avoid contact with eyes

OTC - STOP USE SECTION

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

OTC - DO NOT USE SECTION

  • over raws surfaces, or blistered areas

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

As with all products containing benzocaine, localized allergic reactions may occur after prolonged or repeated use

Inactive ingredients

INACTIVE INGREDIENT SECTION

ALCOHOL DENAT., AQUA/WATER/EAU, PROPYLENE GLYCOL, METHYLPARABEN

Questions or comments?

OTC - QUESTIONS SECTION

Call us at 1-800-953-5080 9:00AM - 5:00PM EST

Principal Display Panel - Sally Hansen Ouch-Relief Wax Strip Kit Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - Sally Hansen Ouch-Relief Wax Strip Kit Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043353benzocaine 6 % Medicated PadPSN5
1043353benzocaine 60 MG/ML Medicated PadSCD5
1043353benzocaine 6 % Medicated WipeSY5
1043353benzocaine 6 % Topical SwabSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66184-162-012023-01-30C16284748780-1f386c64a-4769-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66184-162-01Sally Hansen Ouch-Relief Wax Strip Kit1 in 1 CARTONKIT15
66184-163-01Sally Hansen Ouch-Relief Wax Strip Kit3 in 1 PACKETCLOTH6 g5
66184-163-01Sally Hansen Ouch-Relief Wax Strip Kit1 in 1 APPLICATORCLOTH36 g5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66184-162SALLY HANSEN OUCH-RELIEF WAX STRIP KIT (BENZOCAINE) KIT [COTY US LLC]5Legacy NDC, 3 package rows20211020_30a4912e-c90f-476e-8bd6-048d52bbea96.zip
66184-163SALLY HANSEN OUCH-RELIEF WAX STRIP KIT (BENZOCAINE) KIT [COTY US LLC]5Unmatched20211020_30a4912e-c90f-476e-8bd6-048d52bbea96.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66184-16266184-162-01
66184-16366184-163-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYLPARABENA2I8C7HI9TIACT
BENZOCAINEU3RSY48JW5ACTIB
ETHYLHEXYL ISONONANOATEI6KB4GE3K4INGR
SESAME OILQX10HYY4QVINGR
C13-14 ISOPARAFFINE4F12ROE70INGR
PHENOXYETHANOLHIE492ZZ3TINGR
MENTHOL, UNSPECIFIED FORML7T10EIP3AINGR
METHYLPARABENA2I8C7HI9TINGR
PROPYLPARABENZ8IX2SC1OHINGR
TOCOPHEROLR0ZB2556P8INGR
ETHYLPARABEN14255EXE39INGR
GUAIAZULENE2OZ1K9JKQCINGR
ROSIN88S87KL877INGR
GLYCERYL ROSINATESD112V492JINGR
MINERAL OILT5L8T28FGPINGR
HIGH DENSITY POLYETHYLENEUG00KM4WR7INGR

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ceb50c62-f34a-a4e2-e053-2995a90acd3c30a4912e-c90f-476e-8bd6-048d52bbea962021-10-19WarningsExact identifier
spl id: ceb50c62-f34a-a4e2-e053-2995a90acd3c
spl set id: 30a4912e-c90f-476e-8bd6-048d52bbea96

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.