LEADER MAXIMUM STRENGTH ANTI-ITCH- benzocaine and resorcinol cream

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

Buy It Now

Active ingredient:
Benzocaine 20%, Resorcinol 3%
Available from:
Cardinal Health
Administration route:
VAGINAL
Prescription type:
OTC DRUG
Therapeutic indications:
External Analgesic temporarily relieves itching
Authorization status:
OTC monograph not final
Authorization number:
70000-0369-1

LEADER MAXIMUM STRENGTH ANTI-ITCH- benzocaine and resorcinol cream

Cardinal Health

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.

----------

Drug Facts

Active ingredients

Benzocaine 20%

Resorcinol 3%

Purpos e

External Analgesic

Us e

temporarily relieves itching

Warnings

For external use only

When using this product avoid contact with eyes

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear

up and occur again within a few days. Also, do not use if you have an unusual or abnormal vaginal

discharge except under the supervision of a physician.

Do not apply over large areas of the body

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-

800-222-1222) right away.

Directions

Adults and children 12 years and older

apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily.

Children under 12 years

consult a doctor

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

aloe vera gel, carbomer, cetyl alcohol, corn oil, disodium EDTA, fragrance, glyceryl stearate,

isopropyl myristate, isopropyl palmitate, lanolin, methyl-4 hydroxybenzoate, mineral oil, PEG-100

stearate, propylene glycol, purified water, stearic acid, stearyl alcohol, triethanolamine, vitamin A, E &

Principal Display Panel - 200 mg Carton Label

LEADER™

NDC 70000-0369-1

Maximum Strength

Anti-Itch

Vaginal Cream

Benzocaine, 20% | Resorcinol, 3%

External Analgesic

Principal Display Panel - 200 mg Vial Label

LEADER™

NDC 70000-0369-1

Maximum Strength

Anti-Itch

Vaginal Cream

Fast, Long-Lasting Relief

from Intense Itch

Associated with Irritating Vaginal Conditions

NET WT 1 OZ (28 g)

LEADER MAXIMUM STRENGTH ANTI-ITCH

benzocaine and resorcinol cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 0 0 0 -0 36 9

Route of Administration

VAGINAL, TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

BENZOCAINE

20 0 mg in 1 g

RESO RCINO L (UNII: YUL4LO9 4HK) (RESORCINOL - UNII:YUL4LO9 4HK)

RESORCINOL

30 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

Alo e Vera Lea f (UNII: ZY8 1Z8 3H0 X)

Ca rbo mer Co po lymer Type B ( Allyl Penta erythrito l Cro sslinked) (UNII: 8 0 9 Y72KV36 )

Cetyl Alco ho l (UNII: 9 36 JST6 JCN)

Edeta te Diso dium (UNII: 7FLD9 1C8 6 K)

Glyceryl Mo no stea ra te (UNII: 230 OU9 XXE4)

Iso pro pyl Myrista te (UNII: 0 RE8 K4LNJS)

Iso pro pyl Pa lmita te (UNII: 8 CRQ2TH6 3M)

La no lin (UNII: 7EV6 5EAW6 H)

Po ta ssium Methylpa ra ben (UNII: M6 4U9 71IB0 )

Minera l O il (UNII: T5L8 T28 FGP)

PEG-10 0 Stea ra te (UNII: YD0 1N19 9 9 R)

Pro pylene Glyco l (UNII: 6 DC9 Q16 7V3)

Wa ter (UNII: 0 59 QF0 KO0 R)

Stea ric Acid (UNII: 4ELV7Z6 5AP)

Stea ryl Alco ho l (UNII: 2KR8 9 I4H1Y)

Tro la mine (UNII: 9 O3K9 3S3TK)

Vita min A (UNII: 8 1G40 H8 B0 T)

Vita min D (UNII: 9 VU1KI44GP)

.Alpha .-To co phero l (UNII: H4N8 55PNZ1)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 0 0 0 -0 36 9 -1

1 in 1 CARTON

0 8 /15/20 19

1

28 g in 1 TUBE; 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 no t final

pa rt348

0 8 /15/20 19

Labeler -

Cardinal Health (097537435)

Cardinal Health

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Natural Essentials

9 4748 4713

MANUFACTURE(70 0 0 0 -0 36 9 )

Revised: 8/2019

Similar products

Search alerts related to this product

View documents history

Share this information