MIRAKEL PAIN RELIEF ROLL-ON- lidocaine hcl gel

Mirakel Pain Relief Roll-On by

Drug Labeling and Warnings

Mirakel Pain Relief Roll-On by is a Otc medication manufactured, distributed, or labeled by Sanvio, Inc., Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine HCl 4%

PURPOSE

Topical anesthetic

INDICATIONS & USAGE

Temporarily relieves minor pain.

WARNINGS

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

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, 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.

DOSAGE & 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.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIRAKEL PAIN RELIEF ROLL-ON 
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78589-257
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
METHYLPARABEN (UNII: A2I8C7HI9T)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
ALCOHOL (UNII: 3K9958V90M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
STEARETH-21 (UNII: 53J3F32P58)
GLYCERIN (UNII: PDC6A3C0OX)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHICONE 200 (UNII: RGS4T2AS00)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
SALIX ALBA BARK (UNII: 205MXS71H7)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78589-257-03	85 g in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/01/2023

Labeler - Sanvio, Inc. (100812165)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(78589-257)