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NDC 68726-0445-02 PCA Gel 2 g/100mL Details
PCA Gel 2 g/100mL
PCA Gel is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by CP Skin Health Group, 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: 68726-0445-02Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical
Product Information
| NDC | 68726-0445 |
|---|---|
| Product ID | 68726-445_ec962c47-04a9-f80c-e053-2995a90a6c47 |
| 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 | PCA Gel |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Salicylic Acid |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 2 |
| Active Ingredient Units | g/100mL |
| Substance Name | SALICYLIC ACID |
| Labeler Name | CP Skin Health Group, Inc |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | M006 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 68726-0445-02 (68726044502)
| NDC Package Code | 68726-445-02 |
|---|---|
| Billing NDC | 68726044502 |
| Package | 1 BOTTLE in 1 CARTON (68726-445-02) / 29.5 mL in 1 BOTTLE (68726-445-01) |
| Marketing Start Date | 2020-08-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 396b4675-451f-48b2-b139-19508434e0fe Details
Warnings
Directions
- Clean the skin thoroughly before applying this product
- Cover the entire affected area with a thin layer one to three times daily
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Inactive Ingredients
Alcohol, Butylene Glycol, Cellulose, Denatonium Benzoate, Ethoxydiglycol, Ethyl Linoleate, Hexylresorcinol, Hydroxyethylcellulose, Isopentyldiol, Mandelic Acid, Pentylene Glycol, Polyacrylate Crosspolymer-6, Polyglyceryl-10 Dioleate, Polyglyceryl-10 Dipalmitate, Potassium Hydroxide, Sodium Acetate, t-Butyl Alcohol, Water
INGREDIENTS AND APPEARANCE
| PCA GEL
salicylic acid gel |
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| Labeler - CP Skin Health Group, Inc (611921669) |