santo remedio alivio pain relieving cream lavender scent

santo remedio alivio pain relieving cream lavender scent
SPL v1
SPL
SPL Set ID ab53c7f2-a768-4f36-89d6-e128a1a940c2
Route
topical
Published
Effective Date 2024-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (40 mg)
Inactive Ingredients
aloe vera leaf water cetyl alcohol emu oil ethylhexylglycerin glucosamine sulfate glyceryl monostearate c13-14 isoparaffin isopropyl myristate laureth-7 lavender oil dimethyl sulfone phenoxyethanol polyethylene glycol 400 polysorbate 80 trolamine

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-06-27

Purpose

Topical Analgesic

Description

Lidocaine HCl 4.00% Menthol 1.00%


Medication Information

Warnings

For external use only

Uses
  • For the temporary relief of pain
Purpose

Topical Analgesic

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.
Other Information
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, Glyceryl Stearate, C13-14 Isoparaffin, Isopropyl Myristate, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, PEG-8, Polysorbtate-80, Triethanolamine.

Description

Lidocaine HCl 4.00% Menthol 1.00%

Questions?

855.REMEDIO

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

Package Labeling:

Active Ingredients

Lidocaine HCl 4.00%

Menthol 1.00%

When Using This Product
  • avoid contact with the eyes
Stop Use and Ask 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.


Structured Label Content

Warnings

For external use only

Uses
  • For the temporary relief of pain
Purpose

Topical Analgesic

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.
Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, Glyceryl Stearate, C13-14 Isoparaffin, Isopropyl Myristate, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, PEG-8, Polysorbtate-80, Triethanolamine.

Questions?

855.REMEDIO

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

Package Labeling:

Active Ingredients (Active ingredients)

Lidocaine HCl 4.00%

Menthol 1.00%

When Using This Product (When using this product)
  • avoid contact with the eyes
Stop Use and Ask Doctor If (Stop use and ask 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.


Advanced Ingredient Data


Raw Label Data

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