ASTONEA BURN CREAM- lidocaine cream

ASTONEA Burn Cream by

Drug Labeling and Warnings

ASTONEA Burn Cream by is a Otc medication manufactured, distributed, or labeled by ASTONEA LABS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine HCL 0.5% Topical Analgesic

Benzalkonium Chloride 0.13% Topical Antiseptic

Purpose

Topical Analgesic

Topical Antiseptic

Uses

For temporary relief of pain and itching associated with:

• Sunburn
• Minor burns,
• Insect bites,
• Minor skin irritation,
• Cuts
• Scrapes

Warnings

FOR EXTERNAL USE ONLY

Do Not Use

Do Not Use:

• In the eyes
• Over large areas of the body or on deep puncture wounds, animal bites or serious burns.
• In large quantities, particularly over raw surfaces or blistered areas.

Stop Use

the condition gets worse condition clears up and recurs within a few days condition persists for more than 7 days

If pregnant or breast feeding

ask a health care professional before use.

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 and over:

• clean the affected area
• apply a small amount of this product on the area 3 or 4 times daily.
• may be covered with a sterile bandage

Children under 2 years

• consult a doctor

Other Information

store in a cool, dry area 59°-86°F (15°-30°C) tamper evident sealed packets do not use any opened or torn packets

Inactive ingredients

Aloe barbadensis leaf juice, Cetearyl alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl stearate/PEG-100 stearate, Maltodextrin, Mineral oil, Phenoxyethanol, Propylene glycol, Purified water, Stearic acid, Triethanolamine.

Principal Display Panel

INGREDIENTS AND APPEARANCE

ASTONEA BURN CREAM 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77338-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77338-100-01	0.9 g in 1 PACKET; Type 0: Not a Combination Product	05/16/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/16/2023

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)