SMOOTH GATOR 60-SECOND PAIN RELIEF (camphor- synthetic, menthol cream

SMOOTH GATOR 60-second Pain Relief by

Drug Labeling and Warnings

SMOOTH GATOR 60-second Pain Relief by is a Otc medication manufactured, distributed, or labeled by Smooth Gator LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active ingredients:

Camphor 3.00%

Menthol 1.25%

Purpose:

Topical Analgesic

Indications:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.

Warnings:

• For external use only.
• Avoid contact with eyes.
• If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

• If swallowed, consult physician.
• Do not apply to wounds or damaged skin.
• Do not bandage tightly.

Directions:

• Adults and children two-years of age or older:

• Children under two-year of age: consult a physician

Apply to affected area not more than three to four times daily.

Additional Information:

Store at room temperature.

Inactive ingredients:

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Diazolidinyl Urea, Eucalyptus Globulus Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Methyl Paraben, Methyl Salicylate, PEG-8, PEG-100 Stearate, Polysorbate-20, Propyl Paraben, Propylene Glycol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Retinyl Palmitate (Vitamin A), Rosmarinus Officinalis (Rosemary) Extract, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethanolamine.

Package Labeling:227g

Package Labeling:454g

INGREDIENTS AND APPEARANCE

SMOOTH GATOR 60-SECOND PAIN RELIEF 
camphor (synthetic), menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70673-298
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	30 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	12.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TEA TREE OIL (UNII: VIF565UC2G)
PEPPERMINT OIL (UNII: AV092KU4JH)
METHYLPARABEN (UNII: A2I8C7HI9T)
METHYL SALICYLATE (UNII: LAV5U5022Y)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALMOND OIL (UNII: 66YXD4DKO9)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ROSEMARY (UNII: IJ67X351P9)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70673-298-08	227 g in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2022
2	NDC: 70673-298-16	454 g in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/01/2022

Labeler - Smooth Gator LLC (029819479)