Amp Relief Pain Relief Cream

Amp Relief Pain Relief Cream
SPL v2
SPL
SPL Set ID 39564c67-49ab-42d4-a391-792ac69180c0
Route
TOPICAL
Published
Effective Date 2022-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (80 mg)
Inactive Ingredients
Aloe Vera Leaf Water Arnica Montana Flower Indian Frankincense Ethylhexylglycerin Eucalyptus Oil Glycerin Isopropyl Myristate Methyl Salicylate Mineral Oil Phenoxyethanol Polysorbate 80 Trolamine Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-15

Description

Menthol 8.00%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 8.00%

Uses:
  • For the temporary relief of minor aches and pains of muscles and joints, associated with backache, arthritis, strains, bruises and sprains
Warnings:

For external use only.

Questions?

1(888) 510-6289

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
  • Keep away from excessive heat or open flame.

Flammable:

Do Not Use 
  • on damaged or broken skin
Package Labeling:

Active Ingredients

Menthol 8.00%

Inactive Ingredients:

Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Isopropyl Myristate, Methyl Salicylate, Paraffinum Liquidum, Phenoxyethanol, Polysorbate-80, SD-Alcohol 40B Triethanolamine, FD&C Blue #1, FD&C Yellow #5

When Using Thsi Product 
  • Avoid contact with the eyes.
  • Do not bandage tightly.
Stop Use and Ask A Doctor If
  • rash or irritation develops and lasts
  • condition worsens 
  • symptoms persist for more than 7 days 
  • clears up and occurs again within a few days
If Pregnant Or Breast Feeing,

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. 


Structured Label Content

Uses:
  • For the temporary relief of minor aches and pains of muscles and joints, associated with backache, arthritis, strains, bruises and sprains
Purpose

Topical Analgesic

Warnings:

For external use only.

Questions?

1(888) 510-6289

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
  • Keep away from excessive heat or open flame.

Flammable:

Do Not Use  (Do not use )
  • on damaged or broken skin
Package Labeling:

Active Ingredients

Menthol 8.00%

Inactive Ingredients: (Inactive ingredients:)

Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Isopropyl Myristate, Methyl Salicylate, Paraffinum Liquidum, Phenoxyethanol, Polysorbate-80, SD-Alcohol 40B Triethanolamine, FD&C Blue #1, FD&C Yellow #5

When Using Thsi Product  (When using thsi product )
  • Avoid contact with the eyes.
  • Do not bandage tightly.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash or irritation develops and lasts
  • condition worsens 
  • symptoms persist for more than 7 days 
  • clears up and occurs again within a few days
If Pregnant Or Breast Feeing, (If pregnant or breast-feeing,)

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. 


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Raw Label Data

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