Label: LEADER ANTI-ITCH MAXIMUM STRENGTH- benzocaine and resorcinol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49781-092-01 - Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated January 24, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
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Warnings
For external use only
- Directions
- Other information
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Inactive ingredients
aloe vera gel, carbomer, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate, isopropyl myristate, isopropyl palmitate, lanolin, methyl-4 hydroxybenzoate, mineral oil, PEG-100 stearate, propylene glycol, purified water, stearic acid com oil, stearyl alcohol, triethanolamine, vitamin A, E & D.
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Principal Display Panel - 28 g Carton Label
NDC 49781-092-01
Compare to Vagisil®
Maximum Strength Cream
active ingredients*
LEADER®
MAXIMUM STRENGTH
Anti-Itch Vaginal Cream
Fast, Long-Lasting Relief from Intense Itch
Associated with irritating Vaginal Conditions
For Feminine Itching & Irritation
Fast, Long-Lasting Relief from Intense Itch associated with:
Discharge and Irritating Vaginal Conditions
Satisfaction Guaranteed
NET WT 1 OZ (28g)
- Principal Display Panel - 28 g Tube Label
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INGREDIENTS AND APPEARANCE
LEADER ANTI-ITCH MAXIMUM STRENGTH
benzocaine and resorcinol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49781-092 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg in 1 g RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL 30 mg in 1 g Inactive Ingredients Ingredient Name Strength Aloe Vera Leaf (UNII: ZY81Z83H0X) Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: 809Y72KV36) Cetyl Alcohol (UNII: 936JST6JCN) Edetate Disodium (UNII: 7FLD91C86K) Glyceryl Monostearate (UNII: 230OU9XXE4) Isopropyl Myristate (UNII: 0RE8K4LNJS) Isopropyl Palmitate (UNII: 8CRQ2TH63M) Lanolin (UNII: 7EV65EAW6H) Potassium Methylparaben (UNII: M64U971IB0) Mineral Oil (UNII: T5L8T28FGP) PEG-100 Stearate (UNII: YD01N1999R) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Stearic Acid (UNII: 4ELV7Z65AP) Stearyl Alcohol (UNII: 2KR89I4H1Y) Trolamine (UNII: 9O3K93S3TK) Vitamin A (UNII: 81G40H8B0T) Vitamin D (UNII: 9VU1KI44GP) .Alpha.-Tocopherol (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49781-092-01 1 in 1 CARTON 05/19/2013 1 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 05/19/2013 Labeler - Cardinal Health (097537435) Establishment Name Address ID/FEI Business Operations Natural Essentials 947484713 MANUFACTURE(49781-092)