Freeze Gel by Royal Labs Natural Cosmetics, Inc. / Royal Labs Natural Cosmetics, Inc FREEZE GEL gel

Freeze Gel by

Drug Labeling and Warnings

Freeze Gel by is a Otc medication manufactured, distributed, or labeled by Royal Labs Natural Cosmetics, Inc., Royal Labs Natural Cosmetics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Dosage & Administration Section

Adults and children 12 years of age and older; Rub onto affected area 3 to 4 times daily.

Warnings Section

For external use only.

Inactive Ingredient Section

Inactive Ingredient Section

Indications & Usage Section

Indications & Usage Section

OTC-Keep out of reach of children section

OTC-Keep out of reach of children section

OTC Purpose

OTC Purpose

Principal Display Panel

Royal Labs Hemp Freeze Gel

INGREDIENTS AND APPEARANCE

FREEZE GEL 
freeze gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69580-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)	1 mg  in 100 mL

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69580-500-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/17/2019
2	NDC: 69580-500-02	3785 mL in 1 PAIL; Type 0: Not a Combination Product	12/17/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/17/2019

Labeler - Royal Labs Natural Cosmetics, Inc. (197478480)

Registrant - Royal Labs Natural Cosmetics, Inc (197478480)

Establishment
Name	Address	ID/FEI	Business Operations
Royal Labs Natural Cosmetics, Inc		197478480	manufacture(69580-500)