INSTA RELIEF DM- lidocaine hydrochloride, menthol cream

INSTA RELIEF DM by

Drug Labeling and Warnings

INSTA RELIEF DM by is a Otc medication manufactured, distributed, or labeled by DM LAB CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENTS

Lidocaine HCL 4.00%

Menthol 1.00%

Topical Anesthetic

INDICATIONS:

For the temporary relief of pain and itching assoicated with minor burns sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

WARNINGS

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

Keep out of reach of children.

If swallowed, consult physician.

Do not apply

• to wounds or damaged skin.
• Do not bandage tightly.

If pregnant or breast feeding,

contact 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.

Additional Information:

Store at room temperature.

OTHER INGREDIENTS:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alchol, Caprylic/Capric Triglyceride, Carbomer, Cetearyl Alcohol, Cetereth-20, Cetyl Alcohol, Citrus Aurantifolia (Orange) Oil, Daucus Carota Sativa (Carrot) Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, 1-Arginine, Lavandula Angustifolia (Lavender) Oil, Lecithin, Methylsulfonylmethane (MSM), Phenoxyethanol, Potassium Hydroxide

Package Labeling:

INGREDIENTS AND APPEARANCE

INSTA RELIEF DM 
lidocaine hydrochloride, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72465-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETYL ALCOHOL (UNII: 936JST6JCN)
LIME OIL (UNII: UZH29XGA8G)
CARROT (UNII: L56Z1JK48B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
LAVENDER OIL (UNII: ZBP1YXW0H8)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72465-600-00	118 mL in 1 JAR; Type 0: Not a Combination Product	07/05/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/05/2018

Labeler - DM LAB CORP (099396086)