Apple .025 g/mL
Malus pumila · SOLUTION · Greer Laboratories, Inc.
Apple (Malus Pumila) is an over-the-counter solution administered by intradermal injection at a strength of 0.025 g/mL. This product is not a recognized pharmaceutical drug and has no established drug class or approved medical indication.
Key Facts
- Brand Name
- Apple
- Generic Name
- Malus pumila
- NDC Code (Product)
22840-5700- Manufacturer
- Greer Laboratories, Inc.
- Strength
- .025 g/mL
- Dosage Form
- SOLUTION
- Route
- INTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
- Marketing Status
- Application #
- BLA101833
- Marketing Start
- 09/15/1981
Recall History
Showline Automotive Products, Inc. dba US Soaps Mfg. Company
Microbial Contamination of a Non-Sterile Products: Product was found to be contaminated with the bacteria, Sarcina Lutea.
Elevate Oral Care
LABELING: LABEL MIX-UP.
Tween Brands Inc
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
DermaCare, Inc.
Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.
Grato Holdings, Inc.
Labeling mix-up - Indications on product label are incorrect.
NingBo Huize Commodity Co.,Ltd.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Tropichem Research Labs, Inc.
Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli
SUN PHARMACEUTICAL INDUSTRIES INC
Discoloration
Novartis Consumer Health
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Family Dollar Stores, Llc.
CGMP Deviations: product held outside appropriate storage temperature conditions.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use helps prevent recurrence of flaking and itching associated with dandruff
Dosage & Administration
Directions shake well for manimum dandruff control, use every time you shampoo wet hair, massage onto scalp, rinse, repeat if desired for best results use at least twice a week or as directed by a doctor
Warnings
Warnings For external use only
Adverse Reactions
Adverse reaction Kroger ® DISTRIBUTED BY THE KROGER CO. CINCINNATI, OH 45202 QUESTIONS OR COMMENTS WWW.KROGER.COM PLEASE RECYCLE
Frequently Asked Questions
What is Apple used for?
Apple (Malus Pumila) is an over-the-counter solution administered by intradermal injection at a strength of 0.025 g/mL. This product is not a recognized pharmaceutical drug and has no established drug class or approved medical indication.
Is Apple a controlled substance?
Apple is not classified as a controlled substance by the DEA.
What is the generic name for Apple?
The generic name for Apple is Malus pumila. There are 3 other brand versions of Malus pumila.
What is the NDC code for Apple .025 g/mL?
The NDC (National Drug Code) for Apple .025 g/mL is 22840-5700, listed by Greer Laboratories, Inc..