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NDC 28691-0400-02 Wart Remover 0.4 g/1 Details

Wart Remover 0.4 g/1

Wart Remover is a TOPICAL PLASTER in the HUMAN OTC DRUG category. It is labeled and distributed by Pharmaplast SAE. The primary component is SALICYLIC ACID.

MedlinePlus Drug Summary

Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or birthmarks. Salicylic acid is in a class of medications called keratolytic agents. Topical salicylic acid treats acne by reducing swelling and redness and unplugging blocked skin pores to allow pimples to shrink. It treats other skin conditions by softening and loosening dry, scaly, or thickened skin so that it falls off or can be removed easily.

Related Packages: 28691-0400-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical

Product Information

NDC	28691-0400
Product ID	28691-0400_4172a3f9-e00b-4253-b673-9034ef4bd1e2
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Wart Remover
Proprietary Name Suffix	n/a
Non-Proprietary Name	Salicylic Acid
Product Type	HUMAN OTC DRUG
Dosage Form	PLASTER
Route	TOPICAL
Active Ingredient Strength	0.4
Active Ingredient Units	g/1
Substance Name	SALICYLIC ACID
Labeler Name	Pharmaplast SAE
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part358B
Listing Certified Through	2024-12-31

Package

Package Images

NDC 28691-0400-02 (28691040002)

Pricing Information	N/A
NDC Package Code	28691-0400-2
Billing NDC	28691040002
Package	10 PLASTER in 1 BOX (28691-0400-2)
Marketing Start Date	2019-08-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a581fcf8-b406-48af-b358-87531e3486a2 Details

Drug Facts

Active ingredient

Salicylic acid 40% in a plaster vehicle

Purpose

Wart remover adhesive pads

Indications:

For the removal of common warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface.
For the removal of plantar warts on the bottom of the foot.

The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern.

Warnings

For external use only
Do not use this product on irritated skin, on any area that is infected or reddened, if you are a diabetic, or if you have poor blood circulation.
If discomfort persists, see your doctor.
Do not use on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes.

Keep out of reach of children.

Directions

For removal of Common and Plantar warts:

Wash affected area.
May soak wart in warm water for 5 minutes.
Dry area thoroughly.
Cut plaster to fit wart.
Apply medicated plaster.
Repeat procedure every 48 hours as needed (until wart is removed) for up to 12 weeks.

Inactive ingredient

Pressure sensitive adhesive fabric

SPL UNCLASSIFIED SECTION

CURE-AID®

Pharmaplast

Amria – Alexandria

Egypt

www.Pharmaplast-online.com

Packaging

INGREDIENTS AND APPEARANCE

WART REMOVER

salicylic acid plaster

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:28691-0400
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.4 g

Ingredient Name	Strength
Inactive Ingredients
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYISOBUTYLENE (75000 MW) (UNII: 596C33NS2J)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:28691-0400-1	20 in 1 BOX; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	10/07/2016	08/22/2019
2	NDC:28691-0400-2	10 in 1 BOX; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	08/22/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358B	10/07/2016

Labeler - Pharmaplast SAE (644773319)

Name	Address	ID/FEI	Business Operations
Establishment
Pharmaplast SAE		644773319	manufacture(28691-0400)

Revised: 11/2020

Document Id: 4172a3f9-e00b-4253-b673-9034ef4bd1e2

Set id: a581fcf8-b406-48af-b358-87531e3486a2

Version: 3

Effective Time: 20201107