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NDC 73469-0644-01 Scholls Wellness Company LLC 0.4 g/g Details
Scholls Wellness Company LLC 0.4 g/g
Scholls Wellness Company LLC is a TOPICAL DISC in the HUMAN OTC DRUG category. It is labeled and distributed by Scholls Wellness Company LLC. 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: 73469-0644-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical
Product Information
| NDC | 73469-0644 |
|---|---|
| Product ID | 73469-0644_d655fd40-b3b3-e4f3-e053-2a95a90adae4 |
| 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 | Scholls Wellness Company LLC |
| Proprietary Name Suffix | Duragel Callus Remover |
| Non-Proprietary Name | Salicylic Acid |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | DISC |
| Route | TOPICAL |
| Active Ingredient Strength | 0.4 |
| Active Ingredient Units | g/g |
| Substance Name | SALICYLIC ACID |
| Labeler Name | Scholls Wellness Company LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part358F |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 73469-0644-01 (73469064401)
| NDC Package Code | 73469-0644-1 |
|---|---|
| Billing NDC | 73469064401 |
| Package | 4 POUCH in 1 CARTON (73469-0644-1) / 1 g in 1 POUCH |
| Marketing Start Date | 2021-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b7256b0a-3c7e-139f-e053-2a95a90ad344 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions
Directions
wash affected area and dry thoroughly
if necessary, cut medicated disc to fit callus
apply medicated disc with sticky side adhering to skin
cover medicated disc with enclosed cushion
after 48 hours, remove medicated disc
repeat procedure every 48 hours as needed for up to 14 days (until callus is removed)
may soak callus in warm water for 5 minutes to assist in removal
Other Information
Inactive Ingredients
INGREDIENTS AND APPEARANCE
| SCHOLLS WELLNESS COMPANY LLC
DURAGEL CALLUS REMOVER
salicylic acid disc |
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| Labeler - Scholls Wellness Company LLC (117174744) |