LIDOCREAM 4- lidocaine cream

LidoCream 4 by

Drug Labeling and Warnings

LidoCream 4 by is a Otc medication manufactured, distributed, or labeled by Golden Touch LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 4% W/W

Purpose

Topical Anesthetic

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

For the temporary relief of pain and itching due to

• minor burns
• 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.
• Do not exceed recommended dosage unless directed by a doctor

Stop use and ask a doctor if

• allergic reaction occurs
• condition worsens or does not improve within 7 days  
• Symptoms clear up and return within a few days
• notice any unusual effects such as blurred vision, dizziness or drowsiness, difficulty in breathing, trembling, chest pain or irregular heart beat

Directions

• Adults and children 2 years and older: apply externally to the affected area not more than 3 to 4 times daily   
• Children under 2 years of age: consult a doctor 

Inactive ingredients

Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Glycerin, Glyceryl Monooleate, SD Alcohol 40-B, Simmondsia Chinensis (Jojoba) Seed Oil, Water

Packaging

INGREDIENTS AND APPEARANCE

LIDOCREAM 4 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52763-401
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL OLEATE (UNII: 4PC054V79P)
ALCOHOL (UNII: 3K9958V90M)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52763-401-60	1 in 1 CARTON
1		60 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 final	part346	12/01/2010

Labeler - Golden Touch LLC (194284147)

Establishment
Name	Address	ID/FEI	Business Operations
Golden Touch LLC		194284147	manufacture(52763-401)