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NDC 68927-0819-01 Visco-Gel Medicated Round Callus Removers 17.67 mg/44.18mg Details

Visco-Gel Medicated Round Callus Removers 17.67 mg/44.18mg

Visco-Gel Medicated Round Callus Removers is a TOPICAL DISC in the HUMAN OTC DRUG category. It is labeled and distributed by PEDIFIX, INC.. 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: 68927-0819-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical

Product Information

NDC	68927-0819
Product ID	68927-0819_9c0d13c1-ffdf-6fb3-e053-2a95a90aaa2f
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	Visco-Gel Medicated Round Callus Removers
Proprietary Name Suffix	n/a
Non-Proprietary Name	SALICYLIC ACID
Product Type	HUMAN OTC DRUG
Dosage Form	DISC
Route	TOPICAL
Active Ingredient Strength	17.67
Active Ingredient Units	mg/44.18mg
Substance Name	SALICYLIC ACID
Labeler Name	PEDIFIX, INC.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part358F
Listing Certified Through	2022-12-31

Package

Package Images

NDC 68927-0819-01 (68927081901)

Pricing Information	N/A
NDC Package Code	68927-0819-1
Billing NDC	68927081901
Package	1 CELLO PACK in 1 CONTAINER (68927-0819-1) / 4 PATCH in 1 CELLO PACK / 44.18 mg in 1 PATCH
Marketing Start Date	2013-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 18cc7b39-8665-4c98-9325-44422e7782f6 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Salicylic acid 40%

Purpose

Callus remover

Uses

For the removal of calluses
relieves pain by removing calluses

Warnings

For external use only Use only as directed

Do Not Use

if you are diabetic
on irritated, broken or infected skin
if you have poor blood circulation

If discomfort persists, see your doctor or podiatrist.

KEEP OUT OF REACH OF CHILDREN.

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

Directions

Wash affected area. Soak in warm water for 5 minutes if desired. Dry thoroughly
Apply medicated disk directly over callus
Cover medicated disk with gel pad
After 48 hours, remove medicated disk
Repeat procedure every 48 hours as needed (until callus is removed) for up to 14 days

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)

PRINCIPAL DISPLAY PANEL - 4 Disk Blister Pack

PediFix ®

The Podiatrist's Choice

Since 1885

NEW!

Visco-GEL ®

Medicated Round

Callus Removers

With Salicylic Acid

Instant Pain Relief!

Safely Removes Calluses
Adhesive Gel Cushions

& Protects

Relief

Spot

Maximum

Strength

Washable & Reusable

Effective for Weeks

4 Medicated Disks

4 Cushions

Principal Display Panel - 4 Disk Blister Pack

INGREDIENTS AND APPEARANCE

VISCO-GEL MEDICATED ROUND CALLUS REMOVERS

salicylic acid disc

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68927-0819
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	17.67 mg in 44.18 mg

Ingredient Name	Strength
Inactive Ingredients
POLYVINYL ALCOHOL (UNII: 532B59J990)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
VINYL ACETATE (UNII: L9MK238N77)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68927-0819-1	1 in 1 CONTAINER	06/01/2013
1		4 in 1 CELLO PACK
1		44.18 mg in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358F	06/01/2013

Labeler - PEDIFIX, INC. (122271935)

Name	Address	ID/FEI	Business Operations
Establishment
PEDIFIX, INC.		122271935	label(68927-0819) , pack(68927-0819)

Name	Address	ID/FEI	Business Operations
Establishment
AKRON		186569323	manufacture(68927-0819)

Revised: 1/2020

Document Id: 9c0d13c1-ffdf-6fb3-e053-2a95a90aaa2f

Set id: 18cc7b39-8665-4c98-9325-44422e7782f6

Version: 2

Effective Time: 20200113