SALLY HANSEN OUCH-RELIEF WAX KIT- benzocaine kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)

Available from:

Coty US LLC

INN (International Name):

Benzocaine

Composition:

Benzocaine 0.0543 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

SALLY HANSEN OUCH-RELIEF WAX KIT- BENZOCAINE
COTY US LLC
----------
DRUG FACTS
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
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 – Kit Label
_NEW_
OUCH-RELIEF™
WAX KIT
PAIN-
RELIEF
TECHNOLOGY
FOR FACE AND BODY
Pre-Treatment
Helps Reduce Pain
while Waxing
Results Last Up to
8 Weeks!*
Simply Rinses Off
with Water
*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 TESTED
SALLY HANSEN OUCH-RELIEF WAX KIT
benzocaine kit
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
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
01/01/2012
QUANTITY OF PARTS
PART