Baker's Best Maximum Strength Pain Relief

Baker's Best Maximum Strength Pain Relief
SPL v4
SPL
SPL Set ID 9d160ff1-9c23-4a5d-82b3-82c2e1e7d34d
Route
TOPICAL
Published
Effective Date 2019-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (40 mg)
Inactive Ingredients
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Aloe Vera Leaf Water Cetyl Alcohol Emu Oil Ethylhexylglycerin Glucosamine Sulfate C13-14 Isoparaffin Isopropyl Myristate Laureth-7 Methyl Salicylate Dimethyl Sulfone Polyethylene Glycol 400 Phenoxyethanol Polysorbate 80 Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-08

Description

Lidocaine HCl (4.00%), Menthol (1.00%)


Medication Information

Description

Lidocaine HCl (4.00%), Menthol (1.00%)

Section 55105-1

Pain Reliever

Warnings:

For external use only. • Avoid contact with eyes. • If symptoms persist for more than seven days, discontinue use and consult physician.

Directions:

• Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. • Children under two-years of age: consult a physician.

Do Not Apply
  • to wounds or damaged skin.
  • Do not bandage tightly.
Indications:

For the temporary relief of pain.

Package Labeling:

Active Ingredient:

Lidocaine HCl (4.00%), Menthol (1.00%)

Other Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionize Water), Cetyl Alcohol, Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, C13-14 Isoparaffin, Isopropyl Myristate, Laureth-7, Methyl Salicylate, Methylsulfonylmethane (MSM), PEG-8, Phenoxyethanol, Polyacrylamide, Polysorbate-80, Triethanolamine.

Additional Information:

• Store at room temperature.

If Pregnant Or Breast Feeding,

contact physician prior to use.

Keep Out of Reach Of children. 

If swallowed, consult physician.


Structured Label Content

Section 55105-1 (55105-1)

Pain Reliever

Warnings:

For external use only. • Avoid contact with eyes. • If symptoms persist for more than seven days, discontinue use and consult physician.

Directions:

• Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. • Children under two-years of age: consult a physician.

Do Not Apply (Do not apply)
  • to wounds or damaged skin.
  • Do not bandage tightly.
Indications:

For the temporary relief of pain.

Package Labeling:

Active Ingredient:

Lidocaine HCl (4.00%), Menthol (1.00%)

Other Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionize Water), Cetyl Alcohol, Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, C13-14 Isoparaffin, Isopropyl Myristate, Laureth-7, Methyl Salicylate, Methylsulfonylmethane (MSM), PEG-8, Phenoxyethanol, Polyacrylamide, Polysorbate-80, Triethanolamine.

Additional Information:

• Store at room temperature.

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.


Advanced Ingredient Data


Raw Label Data

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