Lidocaine by Stratus Pharmaceuticals Inc / Tarmac Products Inc LIDOCAINE cream

Lidocaine by

Drug Labeling and Warnings

Lidocaine by is a Otc medication manufactured, distributed, or labeled by Stratus Pharmaceuticals Inc, Tarmac Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Lidocaine 3% (3g in 100g)

Purpose

Local analgesic

Uses

for the temporary relief of pain and itching associated with

• minor burns
• sunburn
• minor cuts
• scrapes
• insect bites
• minor skin irritations

Warnings

For external use only

When using this product

• avoid contact with the eyes
• do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and consult a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days

Lidocaine is NOT approved by FDA to treat teething pain and should NOT be given to infants and young children for this use.

If pregnant or breast-feeding

Ask a health professional before use.

Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately.

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: do not use, consult a doctor.

Other information

Store at 20°C to 25°C (68°F to 77°F)

Inactive ingredients

acrylamide, allantoin, aloe vera extract, benzyl alcohol, c12-15 alkyl benzoate, carbomer, isohexadecane, polysorbate 80, propylene glycol, purified water, sodium acryloydimethyl taurate, sodium laureth sulfate, soy lecithin, tocopheryl acetate.

Questions?

Call us at (800) 442-7882

SPL UNCLASSIFIED SECTION

Distributed by:
Stratus Pharmaceuticals Inc.
Miami, FL 33186

PRINCIPAL DISPLAY PANEL - 85 g Tube Box

STRATUS
PHARMACEUTICALS INC

NDC: 58980-826-85

Net WT. 3 oz. / 85 g

LIDOCAINE CREAM
3%

PAIN RELIEVING CREAM

FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE

INGREDIENTS AND APPEARANCE

LIDOCAINE 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58980-826
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987)	Lidocaine	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Acrylamide (UNII: 20R035KLCI)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
Allantoin (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Benzyl Alcohol (UNII: LKG8494WBH)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISOHEXADECANE (UNII: 918X1OUF1E)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Propylene Glycol (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58980-826-30	1 in 1 BOX	02/15/2024
1		28.35 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58980-826-85	1 in 1 BOX	07/01/2025
2		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M017	02/15/2024

Labeler - Stratus Pharmaceuticals Inc (789001641)

Establishment
Name	Address	ID/FEI	Business Operations
Tarmac Products Inc		059890491	MANUFACTURE(58980-826)