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NDC 68927-3792-01 PediQuick OneStep Wart Removers 11.04 mg/1 Details

PediQuick OneStep Wart Removers 11.04 mg/1

PediQuick OneStep Wart Removers is a TOPICAL PLASTER in the HUMAN OTC DRUG category. It is labeled and distributed by PEDIFIX, INC,. The primary component is SALICYLIC ACID.

Product Information

NDC	68927-3792
Product ID	68927-3792_8383afb5-58cd-bc55-e053-2a91aa0ae08d
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	PediQuick OneStep Wart Removers
Proprietary Name Suffix	n/a
Non-Proprietary Name	SALICYLIC ACID
Product Type	HUMAN OTC DRUG
Dosage Form	PLASTER
Route	TOPICAL
Active Ingredient Strength	11.04
Active Ingredient Units	mg/1
Substance Name	SALICYLIC ACID
Labeler Name	PEDIFIX, INC,
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part358B
Listing Certified Through	2022-12-31

Package

Package Images

NDC 68927-3792-01 (68927379201)

Pricing Information	N/A
NDC Package Code	68927-3792-1
Billing NDC	68927379201
Package	1 CELLO PACK in 1 BLISTER PACK (68927-3792-1) / 14 PLASTER in 1 CELLO PACK
Marketing Start Date	2019-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8383afb5-58cc-bc55-e053-2a91aa0ae08d Details

Active ingredient

Salicylic acid 40%

Purpose

Wart remover

Uses

For the removal of common warts. The common wart is easily recognized by the rough ‘cauliflower-like’ appearance on the surface

Warnings

For external use only

Do Not Use this product

on irritated skin
on any area that is infected or reddened
if you are diabetci
if you have poor blood circulation

If discomfort persists,

see your doctor or podiatrist.

Do nou use on

moles
birthmarks
warts with hair growing from them
genital warts
or warts on the face or mucus membranes.

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control center immediately

Directions

wash affected area
may soak in warm water for 5 minutes
dry area thoroughly
remove bandage from backing
apply medicated strip, positioning medicated area directly over wart
repeat procedure every 48 hours as needed (until wart is removed) fo up to 12 weeks

Other Information

Store between 59° and 86°F (15° and 30°C)

Inactive Ingredients

Polyvinyl Alcohol, Acrylic Copolymer

Questions or Comments?

CALL: 1-800-PEDIFIX (733-4349)

SPL UNCLASSIFIED SECTION

Package LABEL

INGREDIENTS AND APPEARANCE

PEDIQUICK ONESTEP WART REMOVERS

salicylic acid plaster

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68927-3792
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	11.04 mg

Ingredient Name	Strength
Inactive Ingredients
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
BROWN IRON OXIDE (UNII: 1N032N7MFO)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68927-3792-1	1 in 1 BLISTER PACK	05/01/2019
1		14 in 1 CELLO PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358B	05/01/2019

Labeler - PEDIFIX, INC, (122271935)

Name	Address	ID/FEI	Business Operations
Establishment
PEDIFIX, INC.		122271935	label(68927-3792)

Name	Address	ID/FEI	Business Operations
Establishment
AKRON COATING AND ADHESIVES		186569323	manufacture(68927-3792)

Revised: 3/2019

Document Id: 8383afb5-58cd-bc55-e053-2a91aa0ae08d

Set id: 8383afb5-58cc-bc55-e053-2a91aa0ae08d

Version: 1

Effective Time: 20190328