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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

Smooth Gator LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

SMOOTH GATOR FOOT AND LEG RUB- CAMPHOR (SYNTHETIC), MENTHOL CREAM
SMOOTH GATOR LLC
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SMOOTH GATOR FOOT AND LEG RUB
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:
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: