NDC 53113-363

FROZEN ICE FAST PAIN RELIEF

Menthol Camphor (natural)

FROZEN ICE FAST PAIN RELIEF is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Gadal Laboratories, Inc. The primary component is Menthol; Camphor (natural).

• Product ID: 53113-363_e06290e3-85ad-4729-96b0-6f063c656081
• NDC: 53113-363
• Product Type: Human Otc Drug
• Proprietary Name: FROZEN ICE FAST PAIN RELIEF
• Generic Name: Menthol Camphor (natural)
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-11-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: GADAL Laboratories, Inc
• Substance Name: MENTHOL; CAMPHOR (NATURAL)
• Active Ingredient Strength: 4 g/100mL; g/100mL
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 53113-363-03

89 mL in 1 APPLICATOR (53113-363-03)

• Marketing Start Date: 2016-11-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53113-363-03 [53113036303]

FROZEN ICE FAST PAIN RELIEF GEL

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-11-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL	3.5 g/100mL

OpenFDA Data

• SPL SET ID: 636cb454-eef9-4509-96cd-7deeb2abd0ac
• Manufacturer:
  • GADAL Laboratories, Inc
• UNII:
  • L7T10EIP3A
  • N20HL7Q941
• RxNorm Concept Unique ID - RxCUI:
  • 416207

NDC Crossover Matching brand name "FROZEN ICE FAST PAIN RELIEF" or generic name "Menthol Camphor (natural)"

NDC	Brand Name	Generic Name
53113-363	FROZEN ICE FAST PAIN RELIEF	MENTHOL CAMPHOR (NATURAL)
71856-070	Arctic Blast Pain Drops	MENTHOL CAMPHOR (NATURAL)
69822-102	Ice Quake Roll On	MENTHOL CAMPHOR (NATURAL)