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NDC 68927-3295-01 Pedi-Quick One Step Callus Removers 17.67 mg/44.18mg Details
Pedi-Quick One Step Callus Removers 17.67 mg/44.18mg
Pedi-Quick One Step Callus 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.
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: 68927-3295-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical
Product Information
| NDC | 68927-3295 |
|---|---|
| Product ID | 68927-3295_81f2c495-817b-4165-e053-2a91aa0a67e1 |
| 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 | Pedi-Quick One Step Callus Removers |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Salicylic Acid |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | PLASTER |
| 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 | part358B |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 68927-3295-01 (68927329501)
| NDC Package Code | 68927-3295-1 |
|---|---|
| Billing NDC | 68927329501 |
| Package | 1 CELLO PACK in 1 CONTAINER (68927-3295-1) / 4 PATCH in 1 CELLO PACK / 44.18 mg in 1 PATCH |
| Marketing Start Date | 2017-07-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c6b7e849-1328-4d77-a9f2-e04d0b4e873b Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions
- Wash affected area. Soak in warm water for five minutes, if desired. Dry thoroughly.
- Remove bandage from backing
- Apply with medicated area directly over callus
- After 48 hours remove medicated bandage
- Repeat procedure every 48 hours as needed (until callus is removed) for up to 14 days.
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| PEDI-QUICK ONE STEP CALLUS REMOVERS
salicylic acid plaster |
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| Labeler - PEDIFIX, INC. (122271935) |
| Registrant - PEDIFIX, INC. (122271935) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| PEDIFIX, INC. | 122271935 | pack(68927-3295) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akron Coating & Adhesive | 186569323 | manufacture(68927-3295) | |