Sally Hansen Ouch-Relief Stripless Hard Wax Kit

Manufacturer
Coty US LLC | DIAMOND WIPES INTERNATIONAL INC.
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:43:58

Label at a glance#

ProductSally Hansen Ouch-Relief Stripless Hard Wax 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

(Ouch-Relief™ Numbing Wipe)

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 Stripless Hard Wax Kit Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - Sally Hansen Ouch-Relief Stripless Hard Wax Kit Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043353benzocaine 6 % Medicated PadPSN9
1043353benzocaine 60 MG/ML Medicated PadSCD9
1043353benzocaine 6 % Medicated WipeSY9
1043353benzocaine 6 % Topical SwabSY9

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
66184-161-012023-06-29C16284748780-1f386c64a-4001-0266-e053-dadaa90a7c1aSally Hansen Ouch-Relief Stripless Hard Wax Kit
66184-161-012023-01-30C16284748780-1f386c64a-4001-0266-e053-dadaa90a7c1aSally Hansen Ouch-Relief Stripless Hard Wax Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66184-161-01Sally Hansen Ouch-Relief Stripless Hard Wax Kit1 in 1 CARTONKIT19
66184-163-01Sally Hansen Ouch-Relief Stripless Hard Wax Kit1 in 1 APPLICATORCLOTH36 g9
66184-163-01Sally Hansen Ouch-Relief Stripless Hard Wax Kit3 in 1 PACKETCLOTH6 g9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66184-161SALLY HANSEN OUCH-RELIEF STRIPLESS HARD WAX KIT (BENZOCAINE) KIT [COTY US LLC]9Legacy NDC, 3 package rows20241218_92ce352b-b083-4f86-8913-87613a824e5d.zip
66184-163SALLY HANSEN OUCH-RELIEF STRIPLESS HARD WAX KIT (BENZOCAINE) KIT [COTY US LLC]9Unmatched20241218_92ce352b-b083-4f86-8913-87613a824e5d.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66184-16166184-161-01
66184-16366184-163-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

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
2965f3f4-cef9-3b00-e063-6294a90a1de792ce352b-b083-4f86-8913-87613a824e5d2024-12-16WarningsExact identifier
spl id: 2965f3f4-cef9-3b00-e063-6294a90a1de7
spl set id: 92ce352b-b083-4f86-8913-87613a824e5d

Reported adverse events (FAERS/openFDA)#

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