uriflex fast acting analgesic pain relief cream

uriflex fast acting analgesic pain relief cream
SPL v2
SPL
SPL Set ID fb78f705-b838-461d-b42c-8c98d3ca5d09
Route
topical
Published
Effective Date 2019-06-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (45 mg)
Inactive Ingredients
carbomer interpolymer type a (allyl sucrose crosslinked) aloe vera leaf water cetyl alcohol diazolidinyl urea isopropyl myristate methylparaben methyl salicylate polyethylene glycol 400 propylparaben propylene glycol sodium lauryl sulfate trolamine

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-05-20

Purpose

External Analgesic

Description

Menthol 4.50%


Medication Information

Purpose

External Analgesic

Description

Menthol 4.50%

Uses:

For temporary relief of minor aches and pains associated with simple backache, arthritis, bruises, sprains, and strains.

Purposes

External Analgesic

Warnings:

For External Use Only. Avoid Contact With Eyes.

Directions:

Apply directly to affected area. Do not use more than four times per day.

Do Not Apply

to Open Wounds or Damaged Skin. If symptoms persist for more than seven days, discontinue use and consult physician.

Package Labeling:

Active Ingredients

Menthol 4.50%

Other Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Diazolidinyl Urea, Isopropyl Myristate, Methyl Paraben, Methyl Salicylate, PEG-8, Propyl Paraber, Propylene Glycol, Sodium Laruyl Sulfate, Triethanolamine.

If Pregnant Or Breast Feeding,

contact physician prior to use.

Keep Out of Reach of Children.

If swallowed, consult physician. Do not bandage tightly.


Structured Label Content

Uses:

For temporary relief of minor aches and pains associated with simple backache, arthritis, bruises, sprains, and strains.

Purposes

External Analgesic

Warnings:

For External Use Only. Avoid Contact With Eyes.

Directions:

Apply directly to affected area. Do not use more than four times per day.

Do Not Apply (DO NOT Apply)

to Open Wounds or Damaged Skin. If symptoms persist for more than seven days, discontinue use and consult physician.

Package Labeling:

Active Ingredients

Menthol 4.50%

Other Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Diazolidinyl Urea, Isopropyl Myristate, Methyl Paraben, Methyl Salicylate, PEG-8, Propyl Paraber, Propylene Glycol, Sodium Laruyl Sulfate, Triethanolamine.

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

contact physician prior to use.

Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

If swallowed, consult physician. Do not bandage tightly.


Advanced Ingredient Data


Raw Label Data

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