Relief 1.3 g/1.3g
Colloidal Oatmeal 1% · CREAM · Era Organics, Inc.
Relief is a cream containing colloidal oatmeal 1% at 1.3 g/1.3g, taken topical. Manufactured by Era Organics, Inc..
Key Facts
- Brand Name
- Relief
- Generic Name
- Colloidal Oatmeal 1%
- NDC Code (Product)
72400-203- Manufacturer
- Era Organics, Inc.
- Strength
- 1.3 g/1.3g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- M006
- Drug Class
- Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]
- Marketing Start
- 01/01/2024
Recall History
Altaire Pharmaceuticals, Inc.
Lack of Assurance of Sterility
King Bio Inc.
Microbial contamination
Product Quest Manufacturing LLC
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Aaron Industries Inc
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
King Bio Inc.
Microbial contamination
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
Altaire Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Kilitch Healthcare India Limited
Non-Sterility
ARG Laboratories, Inc.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Cardinal Health Inc.
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses for protection against further irritation for temporary relief of burning and irritation due to dryness of the eye
Dosage & Administration
Directions instill 1 to 2 drops in the affected eye(s) as needed
Warnings
Warnings For external use only Do not use this product if solution changes color or becomes cloudy When using this product to avoid contamination, do not touch tip of container to any surface. Replace cap after using. remove contact lenses before using Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Frequently Asked Questions
What is Relief used for?
Relief contains Colloidal Oatmeal 1%. It is a cream taken topical. Consult your doctor for specific uses.
Is Relief a controlled substance?
Relief is not classified as a controlled substance by the DEA.
What is the generic name for Relief?
The generic name for Relief is Colloidal Oatmeal 1%. There are 2 other brand versions of Colloidal Oatmeal 1%.
What is the NDC code for Relief 1.3 g/1.3g?
The NDC (National Drug Code) for Relief 1.3 g/1.3g is 72400-203, listed by Era Organics, Inc..