43473-076, Rocksauce Warming Massage Cream

43473-076, Rocksauce Warming Massage Cream
SPL v1
SPL
SPL Set ID b679ed7b-9d88-4eff-9743-567affe0fe2b
Route
TOPICAL
Published
Effective Date 2025-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (100 mg) Salicylic Acid (200 mg)
Inactive Ingredients
Aloe Vera Leaf Juice Aminomethyl Propanol Ammonium Acryloyldimethyltaurate/vp Copolymer Arnica Montana Flower Capsaicin Cetearyl Alcohol Maltodextrin Phenoxyethanol Potassium Cetyl Phosphate Propylene Glycol .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01

Description

Menthol 10% Methyl Salicylate 20%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 10% Methyl Salicylate 20%

Uses:

Provides soothing heat to sore muscles and joints.

Warnings:

For external use only.

Drug Facts

Directions:

Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68°to 77°F (20° to 25°C)

Active Ingredient

Menthol 10%

Methyl Salicylate 20%

Package Labeling:

Inactive Ingredients:

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALOE BARBADENSIS LEAF JUICE, AMINOMETHYL PROPANOL, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, ARNICA MONTANA FLOWER EXTRACT, CAPSAICIN, CETEARYL ALCOHOL, MALTODEXTRIN, PHENOXYETHANOL, PHENOXYETHANOL ETHYLHEXYLGLYCERIN, POTASSIUM CETYL PHOSPHATE, PROPYLENE GLYCOL, TOCOPHERYL ACETATE, WATER

When Using This Product,

do not take by mouth or place in nostrils, apply to wounds or damaged skin. Use as directed.

Keep Out of Reach of Children.

In case of accidental ingestion, get medical help or call Poison Control Center right away. Not for children 5 years or youger.

Ask A Health Professional Before Use 

if you have senstive skin or are pregnant or breastfeeding. Discontinue use if irritation occurs.


Structured Label Content

Uses: (USES:)

Provides soothing heat to sore muscles and joints.

Purpose (PURPOSE)

Topical Analgesic

Warnings: (WARNINGS:)

For external use only.

Drug Facts (DRUG FACTS)

Directions: (DIRECTIONS:)

Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68°to 77°F (20° to 25°C)

Active Ingredient (ACTIVE INGREDIENT)

Menthol 10%

Methyl Salicylate 20%

Package Labeling:

Inactive Ingredients: (INACTIVE INGREDIENTS:)

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALOE BARBADENSIS LEAF JUICE, AMINOMETHYL PROPANOL, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, ARNICA MONTANA FLOWER EXTRACT, CAPSAICIN, CETEARYL ALCOHOL, MALTODEXTRIN, PHENOXYETHANOL, PHENOXYETHANOL ETHYLHEXYLGLYCERIN, POTASSIUM CETYL PHOSPHATE, PROPYLENE GLYCOL, TOCOPHERYL ACETATE, WATER

When Using This Product, (When using this product,)

do not take by mouth or place in nostrils, apply to wounds or damaged skin. Use as directed.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental ingestion, get medical help or call Poison Control Center right away. Not for children 5 years or youger.

Ask A Health Professional Before Use  (Ask a health professional before use )

if you have senstive skin or are pregnant or breastfeeding. Discontinue use if irritation occurs.


Advanced Ingredient Data


Raw Label Data

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