SALLY HANSEN OUCH-RELIEF STRIPLESS HARD WAX KIT- benzocaine kit

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)
Available from:
Coty US LLC
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
Authorization status:
OTC monograph final
Authorization number:
66184-161-01, 66184-163-01

SALLY HANSEN OUCH-RELIEF STRIPLESS HARD WAX KIT- benzocaine

Coty US LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Sally Hansen Ouch-Relief Stripless Hard Wax Kit

(Ouch-Relief™ Numbing Wipe)

Active ingredient

6% Benzocaine

Purpos e

Topical Analgesic

Us es

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 - Sally Hansen Ouch-Relief Stripless Hard Wax Kit Label

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

SALLY HANSEN OUCH-RELIEF STRIPLESS HARD WAX KIT

benzocaine kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 6 18 4-16 1

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 6 18 4-16 1-0 1

1 in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct

10 /18 /20 18

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

3 APPLICATOR

Pa rt 2

1 PACKET

Pa rt 3

1 JAR

113.4 g

Part 1 of 3

OUCH-RELIEF NUMBING WIPE

benzocaine cloth

Product Information

Ite m Code (Source )

NDC:6 6 18 4-16 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZO CAINE (UNII: U3RSY48 JW5) (BENZOCAINE - UNII:U3RSY48 JW5)

BENZOCAINE

6 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 6 18 4-16 3-0 1

3 in 1 PACKET

1

1 in 1 APPLICATOR; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt348

10 /18 /20 18

Part 2 of 3

AZULENE OIL FINISHING WIPE

other skin care preparations

Product Information

Route of Administration

TOPICAL

Other Ingredients

Ingredient Kind

Ingredient Name

Quantity

INGR

MINERAL O IL (UNII: T5L8 T28 FGP)

INGR

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

INGR

WHEAT GERM O IL (UNII: 14C9 7E6 8 0 P)

INGR

PHENYLETHYL ALCO HO L (UNII: ML9 LGA746 8 )

INGR

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

INGR

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

INGR

GUAIAZULENE (UNII: 2OZ1K9 JKQC)

INGR

ASCO RBYL PALMITATE (UNII: QN8 3US2B0 N)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

4 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Co sme tic

10 /18 /20 18

Part 3 of 3

WAX

other skin care preparations

Product Information

Route of Administration

TOPICAL

Other Ingredients

Ing re die nt

Kind

Ingredient Name

Quantity

INGR

GLYCERYL RO SINATE (UNII: SD112V49 2J)

INGR

PARAFFIN (UNII: I9 O0 E3H2ZE)

INGR

YELLO W WAX (UNII: 2ZA36 H0 S2V)

INGR

PO LYO XYL 4 0 HYDRO GENATED CASTO R O IL (UNII: 7YC6 8 6 GQ8 F)

INGR

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

INGR

MICA (UNII: V8 A1AW0 8 8 0 )

INGR

O AT KERNEL O IL (UNII: 3UVP41R77R)

INGR

CO CO NUT O IL (UNII: Q9 L0 O73W7L)

INGR

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

INGR

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

INGR

LINALO O L, ( +/-) - (UNII: D8 1QY6 I8 8 E)

INGR

.BETA.-CITRO NELLO L, ( R) - (UNII: P0 1OUT9 6 4K)

INGR

GERANIO L (UNII: L8 3710 8 USY)

INGR

.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6 O37OK2I)

INGR

BENZYL BENZO ATE (UNII: N8 6 3NB338 G)

INGR

ISO METHYL-.ALPHA.-IO NO NE (UNII: 9 XP4LC555B)

Coty US LLC

INGR

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

INGR

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

INGR

PENTAERYTHRITO L TETRAKIS( 3 -( 3 ,5-DI-TERT-BUTYL-4 -HYDRO XYPHENYL) PRO PIO NATE)

(UNII: 255PIF6 2MS)

INGR

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

113.4 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Co sme tic

10 /18 /20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt348

10 /18 /20 18

Labeler -

Coty US LLC (039056361)

Revised: 2/2020

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