Mirakel Pain Relief Roll-on

Mirakel Pain Relief Roll-on
SPL v1
SPL
SPL Set ID 102f3618-13ad-37e3-e063-6294a90a8086
Route
TOPICAL
Published
Effective Date 2024-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
C30-45 Alkyl Cetearyl Dimethicone Crosspolymer Caprylyl Trisiloxane Methylparaben Mentha Piperita Leaf Alcohol Cetostearyl Alcohol Water Glyceryl Monostearate Aminomethylpropanol Eucalyptus Oil Aloe Vera Leaf Steareth-21 Glycerin Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Ceteth-20 Phosphate Dihexadecyl Phosphate Edetate Disodium Ethylhexylglycerin Dimethicone 200 Arnica Montana Flower Salix Alba Bark Turmeric

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-01

Description

Lidocaine HCl 4%


Medication Information

Warnings and Precautions

For external use only.

Flammable--keep away from fire or flame.

Do not use

  • if you have an allergic reaction to lidocaine or other local anesthetics
  • on large areas of the body or on cut, irritated, blistered, or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

Stop use and ask a doctor if

  • condition worsens
  • severe burning sensation, redness, rash, or irritation develops
  • symptoms persist for more than 7 days or clear p and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Indications and Usage

Temporarily relieves minor pain.

Dosage and Administration

Clean affected area before applying product. Adults and children 12 years and older: apply to the affected area not more than 3 to 4 times daily. Children under 12 years old: ask a doctor.

Description

Lidocaine HCl 4%

Section 50565-1

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

Section 51727-6

Water, Alcohol Denat., Glyceryl Stearate, Cetearyl Alcohol, Dimethicone, Aminomethyl Propanol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Salix Alba (Willow) Bark Extract, Curcuma Longa (Turmeric) Root Extract, Mentha Piperita (Peppermint) Leaf Extract, Eucalyptus Globulus Leaf Oil, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Ceteth-20 Phosphate, Dicetyl Phosphate, Disodium EDTA, Ethylhexylglycerin, Steareth-21, Methylparaben

Section 51945-4

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

Topical anesthetic

Section 55106-9

Lidocaine HCl 4%


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves minor pain.

Dosage and Administration (34068-7)

Clean affected area before applying product. Adults and children 12 years and older: apply to the affected area not more than 3 to 4 times daily. Children under 12 years old: ask a doctor.

Warnings and Precautions (34071-1)

For external use only.

Flammable--keep away from fire or flame.

Do not use

  • if you have an allergic reaction to lidocaine or other local anesthetics
  • on large areas of the body or on cut, irritated, blistered, or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

Stop use and ask a doctor if

  • condition worsens
  • severe burning sensation, redness, rash, or irritation develops
  • symptoms persist for more than 7 days or clear p and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Water, Alcohol Denat., Glyceryl Stearate, Cetearyl Alcohol, Dimethicone, Aminomethyl Propanol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Salix Alba (Willow) Bark Extract, Curcuma Longa (Turmeric) Root Extract, Mentha Piperita (Peppermint) Leaf Extract, Eucalyptus Globulus Leaf Oil, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Ceteth-20 Phosphate, Dicetyl Phosphate, Disodium EDTA, Ethylhexylglycerin, Steareth-21, Methylparaben

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

Topical anesthetic

Section 55106-9 (55106-9)

Lidocaine HCl 4%


Advanced Ingredient Data


Raw Label Data

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