LIDOCAINE PLUS MAXIMUM STRENGTH PAIN RELIEVING CREAM- lidocaine hydrochloride cream

Lidocaine Plus by

Drug Labeling and Warnings

Lidocaine Plus by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine Hydrochloride 4%

Purpose

Pain Relieving Cream

Indications (Uses)

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

WARNINGS

For external use only.

Avoid contact with the eyes.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Do not use in large quantities, particularly over raw surfaces or blistered areas.

Keep out of reach of children.

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

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.
• Always tighten cap firmly after each use

INACTIVE INGREDIENT

Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Carbomer, Diazolidinyl Urea, Disodium EDTA, DMDM Hydantoin, Fragrance, Menthol, Methylparaben, Polysorbate 20, Propylene Glycol, SD Alcohol 40-B, Triethanolamine, Water, Yellow 5

Other Information

Questions or Comments?

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Lidocaine Plus Maximum Strength Pain Relieving Cream

INGREDIENTS AND APPEARANCE

LIDOCAINE PLUS  MAXIMUM STRENGTH PAIN RELIEVING CREAM
lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	39.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
LAURETH-7 (UNII: Z95S6G8201)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN (UNII: A2I8C7HI9T)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 940 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	green	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0123-3	118 mL in 1 TUBE; Type 0: Not a Combination Product	03/02/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	03/02/2007

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0123) , manufacture(58443-0123) , label(58443-0123) , analysis(58443-0123)