Drugplain

Acne Cleanser 1.15 mg/230mL

salicylic acid · LIQUID · Spa de Soleil

3 Recalls on Record
Plain English

Acne Cleanser is a liquid containing salicylic acid at 1.15 mg/230mL, taken topical. Manufactured by Spa de Soleil.

Key Facts

Brand Name
Acne Cleanser
Generic Name
salicylic acid
NDC Code (Product)
68062-9905
Manufacturer
Spa de Soleil
Strength
1.15 mg/230mL
Dosage Form
LIQUID
Route
TOPICAL
Marketing Status
Application #
M006
Marketing Start
11/19/2023

Recall History

3 Recalls on Record
Class III10/15/2012

Valeant Pharmaceuticals

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.

TerminatedVoluntary: Firm initiated
Class III12/20/2019

Island Kinetics, Inc. d.b.a. CoValence Laboratories

Superpotent Drug: Salicylic acid content is above the firm's specification.

TerminatedVoluntary: Firm initiated
Class II09/12/2025

Private Label Skin Care Inc.

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective345 reports
pruritus274 reports
pain253 reports
rash248 reports
vomiting243 reports
headache242 reports
nausea229 reports
off label use227 reports
drug hypersensitivity224 reports
condition aggravated223 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses For the treatment and management of acne Penetrates pores to eliminate most acne and blemishes Helps prevent development of new acne blemishes and blackheads

Dosage & Administration

Directions Pump a small amount of cleanser into dampened hands, and gently massage over face and neck using a circular motion. Rinse thoroughly with water and pat dry.

Warnings

Warnings For external use only When using this product Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Acne Cleanser used for?

Acne Cleanser contains salicylic acid. It is a liquid taken topical. Consult your doctor for specific uses.

Is Acne Cleanser a controlled substance?

Acne Cleanser is not classified as a controlled substance by the DEA.

What is the generic name for Acne Cleanser?

The generic name for Acne Cleanser is salicylic acid. There are 12 other brand versions of salicylic acid.

What is the NDC code for Acne Cleanser 1.15 mg/230mL?

The NDC (National Drug Code) for Acne Cleanser 1.15 mg/230mL is 68062-9905, listed by Spa de Soleil.

Product NDC

68062-9905

Package NDC

68062-9905-1

Other Salicylic Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)