NDC 69580-500

Freeze Gel

Freeze Gel

Freeze Gel is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Royal Labs Natural Cosmetics, Inc.. The primary component is Menthol.

Product ID69580-500_99ee4cef-c9b0-9caa-e053-2995a90abe53
NDC69580-500
Product TypeHuman Otc Drug
Proprietary NameFreeze Gel
Generic NameFreeze Gel
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2019-12-17
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameRoyal Labs Natural Cosmetics, Inc.
Substance NameMENTHOL
Active Ingredient Strength4 mg/100mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69580-500-01

60 mL in 1 BOTTLE (69580-500-01)
Marketing Start Date2019-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69580-500-01 [69580050001]

Freeze Gel GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-12-17

NDC 69580-500-02 [69580050002]

Freeze Gel GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-12-17

Drug Details

Active Ingredients

IngredientStrength
MENTHOL4.2 mg/100mL

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