Reference Source

Kyron Laboratories Pty Limited · 66-41 · SOUTH AFRICA

For Kyron Laboratories Pty Limited · 66-41 · SOUTH AFRICA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is SOUTH AFRICA; 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 2026-09-16.

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 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?.

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

Source

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