Smooth Gator Foot And Leg Rub

Smooth Gator Foot And Leg Rub
SPL v2
SPL
SPL Set ID 57094238-506b-48c1-8eb9-fe904be80df0
Route
TOPICAL
Published
Effective Date 2022-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (40 mg) Menthol (12.5 mg)
Inactive Ingredients
Aloe Vera Leaf Water Cetyl Alcohol Diazolidinyl Urea Eucalyptus Oil Glyceryl Monostearate C13-14 Isoparaffin Isopropyl Myristate Laureth-7 Tea Tree Oil Peppermint Oil Methylparaben Methyl Salicylate Peg-100 Stearate Polysorbate 20 Propylparaben Propylene Glycol Almond Oil Vitamin A Palmitate Rosemary Stearic Acid .alpha.-tocopherol Acetate Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-01

Description

Camphor 4.00% Menthol 1.25%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Camphor 4.00% Menthol 1.25%

Purpose:

Topical Analgesic

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

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.

Indications:

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

Package Labeling:

Active Ingredients:

Camphor 4.00%

Menthol 1.25%

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.

Additional Information:

Store at room temperature.

Keep Out of Reach of Children.
  • If swallowed, consult physician.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.

Structured Label Content

Purpose:

Topical Analgesic

Warnings:
  • For external use only.
  • Avoid contact with eyes.
  • If symptoms persist for more than seven days, discontinue use and consult physician.
Drug Facts (DRUG FACTS)

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.

Indications:

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

Package Labeling:

Active Ingredients: (Active ingredients:)

Camphor 4.00%

Menthol 1.25%

Inactive Ingredients: (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.

Additional Information:

Store at room temperature.

Keep Out of Reach of Children. (Keep out of reach of children.)
  • If swallowed, consult physician.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)