Smooth Gator 60-second Pain Relief

Smooth Gator 60-second Pain Relief
SPL v2
SPL
SPL Set ID 3b74b542-202f-469e-8025-4372e95e6b01
Route
TOPICAL
Published
Effective Date 2022-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (30 mg) Menthol (12.5 mg)
Inactive Ingredients
Aloe Vera Leaf Water Cetyl Alcohol Diazolidinyl Urea Eucalyptus Oil Lavender Oil Tea Tree Oil Peppermint Oil Methylparaben Methyl Salicylate Polyethylene Glycol 400 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 3.00% Menthol 1.25%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Camphor 3.00% 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 associated with arthritis, simple backache, sprains, bruises and strains.

Active Ingredients:

Camphor 3.00%

Menthol 1.25%

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

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 associated with arthritis, simple backache, sprains, bruises and strains.

Active Ingredients: (Active ingredients:)

Camphor 3.00%

Menthol 1.25%

Inactive Ingredients: (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

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

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