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NDC 68927-3062-01 caring mill One-Step Corn Removers 4.42 mg/1 Details

caring mill One-Step Corn Removers 4.42 mg/1

caring mill One-Step Corn Removers is a TOPICAL STRIP in the HUMAN OTC DRUG category. It is labeled and distributed by PEDIFIX, INC.. The primary component is SALICYLIC ACID.

Product Information

NDC	68927-3062
Product ID	68927-3062_b7b1e9f7-8eed-92d4-e053-2a95a90ad4fd
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	caring mill One-Step Corn Removers
Proprietary Name Suffix	n/a
Non-Proprietary Name	SALICYLIC ACID
Product Type	HUMAN OTC DRUG
Dosage Form	STRIP
Route	TOPICAL
Active Ingredient Strength	4.42
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	part358F
Listing Certified Through	2022-12-31

Package

Package Images

NDC 68927-3062-01 (68927306201)

Pricing Information	N/A
NDC Package Code	68927-3062-1
Billing NDC	68927306201
Package	2 BAG in 1 BAG (68927-3062-1) / 6 STRIP in 1 BAG
Marketing Start Date	2021-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b7b1e9f7-8eec-92d4-e053-2a95a90ad4fd Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Salicylic acid 40%

Purpose

Corn remover

Uses

For the removal of corns
Relieves pain by removing corns

Warnings

For external use only Use only as directed

Do Not Use this product

On irritated skin, or on any area that is infected or reddened
If you are diabetic
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
Remove bandages from backing
Apply with medicated area directly over corn
After 48 hours, remove medicated bandage
Repeat procedures every 48 hours as needed (until corn 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: 1800-PEDIFIX (733-4349)

PRINCIPAL DISPLAT PANEL - 12 Bandage Package

caring mill™ One-Step Corn Removers

Easy, one-step application
Stays on all day
Removes corns fast
With as few as 2 treatments
Salicylic acid 40%

12 Count

INGREDIENTS AND APPEARANCE

CARING MILL ONE-STEP CORN REMOVERS

salicylic acid strip

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68927-3062
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	4.42 mg

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68927-3062-1	2 in 1 BAG	01/01/2021
1		6 in 1 BAG; 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	01/01/2021

Labeler - PEDIFIX, INC. (122271935)

Registrant - PEDIFIX, INC. (122271935)

Name	Address	ID/FEI	Business Operations
Establishment
PEDIFIX, INC.		122271935	label(68927-3062) , pack(68927-3062)

Name	Address	ID/FEI	Business Operations
Establishment
AKRON		186569323	manufacture(68927-3062)

Revised: 1/2021

Document Id: b7b1e9f7-8eed-92d4-e053-2a95a90ad4fd

Set id: b7b1e9f7-8eec-92d4-e053-2a95a90ad4fd

Version: 1

Effective Time: 20210101