Lifelabs, A Division Of Atico International Usa, Inc.

Lifelabs, A Division Of Atico International Usa, Inc.
SPL v7
SPL
SPL Set ID 71197538-9317-43cb-a370-85277ee5889f
Route
TOPICAL
Published
Effective Date 2010-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Methyl Salicylate (300 mg) Menthol (100 mg) Camphor (synthetic) (40 mg)
Inactive Ingredients
Diethanolamine Cetyl Phosphate Isopropyl Myristate Glycerin Methylparaben Polysorbate 60 Lanolin Propylparaben Water Sorbitan Monostearate Stearyl Alcohol Petrolatum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-11-01

Description

Active Ingredients Methyl Salicylate - 30%, Menthol - 10%, Camphor - 4%


Medication Information

Warnings and Precautions

Warnings

For external use only. Use only as directed. Keep out of reach of children to avoid accidental poisoning.

  • avoid contact with eyes or mucous membranes.
  • discontinue use if excessive irritation of the skin develops.
  • do not bandage tightly, apply to wounds, or damaged skin, or use with a heating pad
  • if condition worsens, or if symptoms persist for more than 7 days or clear-up and occur again within a few days, consult a doctor

  • if skin redness or irritation develops, discontinue use of this product and consult a doctor.
  • if swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage
Uses

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

Dosage and Administration

Directions

  • Adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily

  • Children under 12 years of age: consult a doctor.
Description

Active Ingredients Methyl Salicylate - 30%, Menthol - 10%, Camphor - 4%

Section 44425-7

Other Information

  • Store at controlled room temperature 15o to 30o C (59o to 86oF)
  • Lot No. and Exp. Date: see box or see crimp of tube

Section 50565-1

Keep out of reach of children to avoid accidental poisoning.

Section 51727-6

Inactive Ingredients

dea-cetyl phosphate, isopropyl myristate, glycerin, methylparaben, polysorbate 60, purefied lanolin, propylparaben, purified water, sorbitan monostearate, stearyl alcohol, white petrolatum
Section 51945-4


Section 53413-1


Questions? Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.

Section 55105-1

Purpose

External Analgesic

Muscle Rub (maximum Strength)

Active Ingredients

Methyl Salicylate - 30%, Menthol - 10%, Camphor - 4%


Structured Label Content

Indications and Usage (34067-9)
Uses

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

Dosage and Administration (34068-7)

Directions

  • Adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily

  • Children under 12 years of age: consult a doctor.
Warnings and Precautions (34071-1)

Warnings

For external use only. Use only as directed. Keep out of reach of children to avoid accidental poisoning.

  • avoid contact with eyes or mucous membranes.
  • discontinue use if excessive irritation of the skin develops.
  • do not bandage tightly, apply to wounds, or damaged skin, or use with a heating pad
  • if condition worsens, or if symptoms persist for more than 7 days or clear-up and occur again within a few days, consult a doctor

  • if skin redness or irritation develops, discontinue use of this product and consult a doctor.
  • if swallowed, get medical help or contact a Poison Control Center right away.

Section 44425-7 (44425-7)

Other Information

  • Store at controlled room temperature 15o to 30o C (59o to 86oF)
  • Lot No. and Exp. Date: see box or see crimp of tube

Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental poisoning.

Section 51727-6 (51727-6)

Inactive Ingredients

dea-cetyl phosphate, isopropyl myristate, glycerin, methylparaben, polysorbate 60, purefied lanolin, propylparaben, purified water, sorbitan monostearate, stearyl alcohol, white petrolatum
Section 51945-4 (51945-4)


Section 53413-1 (53413-1)


Questions? Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.

Section 55105-1 (55105-1)

Purpose

External Analgesic

Muscle Rub (maximum Strength) (Muscle Rub (Maximum Strength))

Active Ingredients

Methyl Salicylate - 30%, Menthol - 10%, Camphor - 4%


Advanced Ingredient Data


Raw Label Data

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