Rapid Pain-relief Topical Cream

Rapid Pain-relief Topical Cream
SPL v2
SPL
SPL Set ID a06d6aca-9aa2-4bbe-bf77-4c85f1dd7870
Route
TOPICAL
Published
Effective Date 2022-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (40 mg)
Inactive Ingredients
Aloe Vera Leaf Water Arnica Montana Flower Ascorbic Acid Indian Frankincense Medium-chain Triglycerides Carbomer Homopolymer, Unspecified Type Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Cetyl Alcohol Ethylhexylglycerin Glycerin Ilex Paraguariensis Leaf Magnesium Sulfate, Unspecified Form Dimethyl Sulfone Methyl Salicylate Phenoxyethanol Potassium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-01

Description

Lidocaine HCL 4.00% Menthol 1.00%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Lidocaine HCL 4.00% Menthol 1.00%

Uses:
  • For the temporary relief of pain.
Warnings:

not intended for ingestion. For external use only

Do Not Use
  • in large quantities, particularly raw surfaces or blistered areas. 
Drug Facts

Questions?

(800) 564-1408

Directions:
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a doctor.
Active Ingredients

Lidocaine HCL 4.00% Menthol 1.00%

Other Information:
  • Store at 20-25°C (68-77°F) and protect from moisture.
Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Ascorbic Acid (Vitamin C), Boswellia Serrata Extract, Caprylic/Capric Triglyceride, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis (Yerba Mate’) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Methyl salicylate, Phenoxyethanol, Potassium Hydroxide.

When Using This Product
  • Avoid contact with eyes
Stop Use and Ask A Doctor If

Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help, or contact a Poison Control Center right away.

Package Labeling: Rapid Pain Relief Topical Cream, 2oz/60ml

Package Labeling: Rapid Pain Relief Topical Cream, 6oz/175ml


Structured Label Content

Uses:
  • For the temporary relief of pain.
Purpose

Topical Analgesic

Warnings:

not intended for ingestion. For external use only

Do Not Use (Do not use)
  • in large quantities, particularly raw surfaces or blistered areas. 
Drug Facts

Questions?

(800) 564-1408

Directions:
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a doctor.
Active Ingredients (Active ingredients)

Lidocaine HCL 4.00% Menthol 1.00%

Other Information: (Other information:)
  • Store at 20-25°C (68-77°F) and protect from moisture.
Inactive Ingredients: (Inactive ingredients:)

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Ascorbic Acid (Vitamin C), Boswellia Serrata Extract, Caprylic/Capric Triglyceride, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis (Yerba Mate’) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Methyl salicylate, Phenoxyethanol, Potassium Hydroxide.

When Using This Product (When using this product)
  • Avoid contact with eyes
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

If swallowed, get medical help, or contact a Poison Control Center right away.

Package Labeling: Rapid Pain Relief Topical Cream, 2oz/60ml (Package Labeling: RAPID PAIN-RELIEF TOPICAL CREAM, 2oz/60ml)

Package Labeling: Rapid Pain Relief Topical Cream, 6oz/175ml (Package Labeling: RAPID PAIN-RELIEF TOPICAL CREAM, 6oz/175ml)


Advanced Ingredient Data


Raw Label Data

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