SMOOTH GATOR FOOT AND LEG RUB (camphor- synthetic, menthol cream

SMOOTH GATOR Foot and Leg Rub by

Drug Labeling and Warnings

SMOOTH GATOR Foot and Leg Rub 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 4.00%

Menthol 1.25%

Purpose:

Topical Analgesic

Indications:

For the temporary relief of minor aches and pains of the muscles and joints.

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:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Diazolidinyl Urea, Eucalyptus Globulus Oil, Glyceryl Stearate, C13-14 Isoparaffin, Isopropyl Myristate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Methyl Paraben, Methyl Salicylate, PEG-100 Stearate, Polyacrylamide, 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:

INGREDIENTS AND APPEARANCE

SMOOTH GATOR FOOT AND LEG RUB 
camphor (synthetic), menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70673-297
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	40 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)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAURETH-7 (UNII: Z95S6G8201)
TEA TREE OIL (UNII: VIF565UC2G)
PEPPERMINT OIL (UNII: AV092KU4JH)
METHYLPARABEN (UNII: A2I8C7HI9T)
METHYL SALICYLATE (UNII: LAV5U5022Y)
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: 70673-297-08	227 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)