Biological Md Solutions (as Pld) - Med O-3 Bio-cream (83538-101)

Biological Md Solutions (as Pld) - Med O-3 Bio-cream (83538-101)
SPL v2
SPL
SPL Set ID 02707552-03d9-3ad2-e063-6294a90a3472
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
Polysorbate 60 Propylparaben Stearic Acid Borage Oil Stearyl Alcohol Edetate Sodium Tocopherol Cetyl Alcohol Cetostearyl Alcohol Water Eucalyptus Oil Methylparaben 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 Propylene Glycol

Identifiers & Packaging

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

Description

METHYL SALICYLATE 10% MENTHOL 1% CAPSAICIN 0.03%

Purpose

TOPICAL ANALGESIC


Medication Information

Purpose

TOPICAL ANALGESIC

Description

METHYL SALICYLATE 10% MENTHOL 1% CAPSAICIN 0.03%

Uses

FAST ACTING

DEEP PENETRATING

HOURS OF RELIEF FOR

  • ARTHRITIS
  • BACKACHE
  • MUSCLE ACHE
  • JOINT PAIN
  • SPRAINS
  • SPORTS INJURIES
  • TENDON INFLAMMATION
  • OVER-USE INJURIES
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. USE ONLY AS DIRECTED.

Section 51945-4

Warnings

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.

FOR TEMPORARY RELIEF.

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.

Questions?

EMAIL US AT [email protected]

Active Ingredients

METHYL SALICYLATE 10%

MENTHOL 1%

CAPSAICIN 0.03%

Inactive Ingredients

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)

FAST ACTING

DEEP PENETRATING

HOURS OF RELIEF FOR

  • ARTHRITIS
  • BACKACHE
  • MUSCLE ACHE
  • JOINT PAIN
  • SPRAINS
  • SPORTS INJURIES
  • TENDON INFLAMMATION
  • OVER-USE INJURIES
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. USE ONLY AS DIRECTED.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

TOPICAL ANALGESIC

Warnings (WARNINGS)

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.

FOR TEMPORARY RELIEF.

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.

Questions? (QUESTIONS?)

EMAIL US AT [email protected]

Active Ingredients (ACTIVE INGREDIENTS)

METHYL SALICYLATE 10%

MENTHOL 1%

CAPSAICIN 0.03%

Inactive Ingredients (INACTIVE INGREDIENTS)

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

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