Label: SALLY HANSEN OUCH-RELIEF WAX KIT - benzocaine
- NDC Code(s): 66184-153-01
- Packager: Coty US LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active ingredient
for temporary relief of pain and itching associated with minor skin irritations due to hair removalClose
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.
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.
- 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 doctorClose
- Other information
As with all products containing benzocaine, localized allergic reactions may occur after prolonged or repeated use.Close
- Inactive ingredients
ALCOHOL DENAT., AQUA/WATER/EAU, PROPYLENE GLYCOL, METHYLPARABENClose
- Questions or comments?
Call us at 1-800-953-5080 9:00AM - 5:00PM ESTClose
- PRINCIPAL DISPLAY PANEL
Principal Display Panel – Kit Label
FOR FACE AND BODY
Helps Reduce Pain
Results Last Up to
Simply Rinses Off
*Individual hair re-growth
results may vary
Wax Net wt. 6.7 oz 189.9 g, 5 Benzocaine wipes,
20 Strips, 1 Spatula for face and body, Instructions
Dermatologist & Salon TestedClose
- INGREDIENTS AND APPEARANCE
SALLY HANSEN OUCH-RELIEF WAX KIT
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66184-153 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66184-153-01 1 in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 PACKET 5 Part 2 1 JAR 189.9 g Part 1 of 2 OUCH-RELIEF
Product Information Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 0.0543 g Inactive Ingredients Ingredient Name Strength Alcohol Water Denatonium Benzoate Propylene Glycol Methylparaben Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 5 in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 01/01/2012 Part 2 of 2 OUCH RELIEF WAX KIT
Product Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Fructose INGR Dextrose INGR Invert Sugar INGR Sucrose INGR Water INGR Phenoxyethanol INGR Glycerin INGR Mica INGR Ethylhexylglycerin INGR Titanium Dioxide INGR honey INGR Acetic Acid INGR Coumarin INGR Tocopherol Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 189.9 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 01/01/2012 Labeler - Coty US LLC (789573201) Establishment Name Address ID/FEI Business Operations Coty US LLC 039056361 MANUFACTURE(66184-153)