Reference Source

Kyron Laboratories Pty Limited · 66-41 · SOUTH AFRICA

For Kyron Laboratories Pty Limited, import alert is 66-41; country is SOUTH AFRICA; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; product is Arnica Ice Cooling Gel | Arnica Ice Cooling Gel | Arnica Ice Cooling Gel; product code is 60 L - - 99 Analgesic, N.E.C. | 62 M - - 08 Menthol (Anti-Pruritic) | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 08/09/2016; address is 29 Barney Road , Johannesburg, Gauteng SOUTH AFRICA, verified against its source on 2026-10-01.

Firm
Kyron Laboratories Pty Limited verified
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
SOUTH AFRICA verified
Address
29 Barney Road , Johannesburg, Gauteng SOUTH AFRICA verified
Date published
08/09/2016 verified
Product code
60 L - - 99 Analgesic, N.E.C. | 62 M - - 08 Menthol (Anti-Pruritic) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
Product
Arnica Ice Cooling Gel | Arnica Ice Cooling Gel | Arnica Ice Cooling Gel each item verified
FDA notes
The product appears to be an unapproved new drug as the product labeling includes claims such as; ?A cooling gel as an aid in the relief of stiffness and soreness; painful muscles; tendons and joints?; and ?Effective as a pre- and post- workout rub for all muscular aches and pains?. | The product appears to be an unapproved new drug as the product labeling includes claims such as; ?A cooling gel as an aid in the relief of stiffness and soreness; painful muscles; tendons and joints?; and ?Effective as a pre- and post- workout rub for all muscular aches and pains?. | The product appears to be an unapproved new drug as the product labeling includes claims such as; ?A cooling gel as an aid in the relief of stiffness and soreness; painful muscles; tendons and joints?; and ?Effective as a pre- and post- workout rub for all muscular aches and pains?. each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Kyron Laboratories Pty Limited Date Published : 08/09/2016 29 Barney Road , Johannesburg, Gauteng SOUTH AFRICA

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code, Product and FDA notes

60 L - - 99 Analgesic, N.E.C. Date Published: 08/09/2016 Desc: Arnica Ice Cooling Gel Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?A cooling gel as an aid in the relief of stiffness and soreness; painful muscles; tendons and joints?; and ?Effective as a pre- and post- workout rub for all muscular aches and pains?. 62 M - - 08 Menthol (Anti-Pruritic) Date Published: 08/09/2016 Desc: Arnica Ice Cooling Gel Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?A cooling gel as an aid in the relief of stiffness and soreness; painful muscles; tendons and joints?; and ?Effective as a pre- and post- workout rub for all muscular aches and pains?. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 08/09/2016 Desc: Arnica Ice Cooling Gel Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as; ?A cooling gel as an aid in the relief of stiffness and soreness; painful muscles; tendons and joints?; and ?Effective as a pre- and post- workout rub for all muscular aches and pains?.

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

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