Biological Md Solutions (as Pld) - Oprava (83538-102)

Biological Md Solutions (as Pld) - Oprava (83538-102)
SPL v2
SPL
SPL Set ID 05552560-e283-5eba-e063-6294a90a65f7
Route
TOPICAL
Published
Effective Date 2023-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 g) Capsaicin (0.03 g) Menthol (1 g)
Inactive Ingredients
Propylparaben Polysorbate 60 Stearic Acid Borage Oil Stearyl Alcohol Edetate Sodium Tocopherol Methylparaben Cetyl Alcohol Cetostearyl Alcohol Water Eucalyptus Oil Propylene Glycol Atlantic Salmon Oil Sodium Hydroxide Olive Oil Phenoxyethanol Squalane Fructose .alpha.-tocopherol Acetate Grape Seed Oil Carbomer Homopolymer, Unspecified Type Lavender Oil Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-08
Description

METHYL SALICYLATE 10% MENTHOL 1% CAPSAICIN 0.03%

Purpose

FOR TEMPORARY PAIN RELIEF

Medication Information

Purpose

FOR TEMPORARY PAIN RELIEF

Description

METHYL SALICYLATE 10% MENTHOL 1% CAPSAICIN 0.03%

Uses

TEMPORARILY RELIEVES

  • ARTHRITIS
  • MUSCLE PAIN
  • INFLAMMATION
Section 44425-7

STORE AT CONTROLLED ROOM TEMPERATURE. 59° - 86°F (15° - 30°C).

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATELY.

Section 51945-4

Warning

FOR EXTERNAL USE ONLY.

  • AVOID CONTACT WITH EYES, MUCOUS MEMBRANES AND BROKEN OR IRRITATED SKIN.
  • IF CONDITION WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS, OR IF REDNESS IS PRESENT, DISCONTINUE USE AND CONSULT A PHYSICIAN.

USE ONLY AS DIRECTED.

NOT FOR USE IN CHILDREN UNDER 12 YEARS OF AGE.

Directions
  • APPLY GENEROUSLY.
  • GENTLY MASSAGE INTO PAINFUL AREA UNTIL THOROUGHLY ABSORBED.
  • REPEAT AS NECESSARY, UP TO FOUR TIMES DAILY.
  • PRODUCT CAN BE USED WITH A WRAP.
Active Ingredients

METHYL SALICYLATE 10%

MENTHOL 1%

CAPSAICIN 0.03%

Inactive Ingredients

ALOE VERA, VITAMINS A AND E, ANTIOXIDANTS, ALOE BARBADENSIS LEAF JUICE, BORAGE OIL, CARBOMER, CETEARYL ALCOHOL, CETYL ALCOHOL, DEIONIZED WATER, EUCALYPTUS GLOBULUS LEAF OIL, FRUCTOSE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, METHYL PARABEN, OLEA EUROPAEA (OLIVE) FRUIT OIL, PHENOXYETHANOL, POLYSORBATE-60, PROPYL PARABEN, PROPYLENE GLYCOL, SALMON OIL, SODIUM HYDROXIDE, SQUALANE, STEARYL ALCOHOL, STEARIC ACID, TETRASODIUM EDTA, TOCOPHEROL, TOCOPHERYL ACETATE, VITIS VINIFERA (GRAPE) SEED OIL

Structured Label Content

Uses (USES)

TEMPORARILY RELIEVES

  • ARTHRITIS
  • MUSCLE PAIN
  • INFLAMMATION
Section 44425-7 (44425-7)

STORE AT CONTROLLED ROOM TEMPERATURE. 59° - 86°F (15° - 30°C).

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATELY.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

FOR TEMPORARY PAIN RELIEF

Warning (WARNING)

FOR EXTERNAL USE ONLY.

  • AVOID CONTACT WITH EYES, MUCOUS MEMBRANES AND BROKEN OR IRRITATED SKIN.
  • IF CONDITION WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS, OR IF REDNESS IS PRESENT, DISCONTINUE USE AND CONSULT A PHYSICIAN.

USE ONLY AS DIRECTED.

NOT FOR USE IN CHILDREN UNDER 12 YEARS OF AGE.

Directions (DIRECTIONS)
  • APPLY GENEROUSLY.
  • GENTLY MASSAGE INTO PAINFUL AREA UNTIL THOROUGHLY ABSORBED.
  • REPEAT AS NECESSARY, UP TO FOUR TIMES DAILY.
  • PRODUCT CAN BE USED WITH A WRAP.
Active Ingredients (ACTIVE INGREDIENTS)

METHYL SALICYLATE 10%

MENTHOL 1%

CAPSAICIN 0.03%

Inactive Ingredients (INACTIVE INGREDIENTS)

ALOE VERA, VITAMINS A AND E, ANTIOXIDANTS, ALOE BARBADENSIS LEAF JUICE, BORAGE OIL, CARBOMER, CETEARYL ALCOHOL, CETYL ALCOHOL, DEIONIZED WATER, EUCALYPTUS GLOBULUS LEAF OIL, FRUCTOSE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, METHYL PARABEN, OLEA EUROPAEA (OLIVE) FRUIT OIL, PHENOXYETHANOL, POLYSORBATE-60, PROPYL PARABEN, PROPYLENE GLYCOL, SALMON OIL, SODIUM HYDROXIDE, SQUALANE, STEARYL ALCOHOL, STEARIC ACID, TETRASODIUM EDTA, TOCOPHEROL, TOCOPHERYL ACETATE, VITIS VINIFERA (GRAPE) SEED OIL

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:27.648385 · Updated: 2026-03-14T23:07:19.548615