Alcohol Free .7 mg/mL
Cetylpyridinium cloride · MOUTHWASH · H E B
Alcohol Free is a mouthwash containing cetylpyridinium cloride at .7 mg/mL, taken oral. Manufactured by H E B.
Key Facts
- Brand Name
- Alcohol Free
- Generic Name
- Cetylpyridinium cloride
- NDC Code (Product)
37808-299- Manufacturer
- H E B
- Strength
- .7 mg/mL
- Dosage Form
- MOUTHWASH
- Route
- ORAL
- Marketing Status
- Application #
- 505G(a)(3)
- Marketing Start
- 04/16/2009
Recall History
HLI dba Humphreyline Inc
Microbial Contamination of Non-Sterile Product
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Perrigo Company PLC
Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
S.C. Johnson Professional
CGMP Deviations: Product was released to market prior to microbiological testing.
KVK-Tech, Inc.
Presence of Foreign Substance; Fiber particles.
Novis PR, Inc.
Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.
LNK International, Inc.
Microbial contamination of non-sterile product
Mangiacotti
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Ultra Chem Labs Corp
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Hillyard GMP
Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use Reduces underarm wetness.
Dosage & Administration
Directions Apply to underarms only.
Warnings
Warnings Ask a doctor before use if you have kidney disease. Stop use if rash or irritation occurs. Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center immediately. Use only as directed.
Frequently Asked Questions
What is Alcohol Free used for?
Alcohol Free contains Cetylpyridinium cloride. It is a mouthwash taken oral. Consult your doctor for specific uses.
Is Alcohol Free a controlled substance?
Alcohol Free is not classified as a controlled substance by the DEA.
What is the generic name for Alcohol Free?
The generic name for Alcohol Free is Cetylpyridinium cloride. There are no other listed brand versions of Cetylpyridinium cloride.
What is the NDC code for Alcohol Free .7 mg/mL?
The NDC (National Drug Code) for Alcohol Free .7 mg/mL is 37808-299, listed by H E B.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)