Sally Hansen Ouch-relief Wax Strip Kit
FDA Label NDC 66184-162

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Coty Us Llc for the product Sally Hansen Ouch-relief Wax Strip Kit (NDC 66184-162). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, when using this product, otc - stop use, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

(Benzocaine Wipes)

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

Otc - Stop Use

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 Wax Strip Kit Label

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)

* Please review the disclaimer below.