SAFLY BURN- lidocaine hydrochloride cream

SAFLY Burn by

Drug Labeling and Warnings

SAFLY Burn by is a Otc medication manufactured, distributed, or labeled by Nantong Health & Beyond Hygienic Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Benzalkonium Chloride 0.13%

Lidocaine HCI         0.5%

PURPOSE

Purpose

First Aid Antiseptic
Topical Analgesic

INDICATIONS & USAGE

Uses

Temporary relief of pain associated with minor cuts, scrapes, and burns.
Helps protect against harmful bacteria.

WARNINGS

Warnings

For external use only.

Do not use

• in eyes
• in large quantities
• over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
• for more than one week unless directed by a doctor

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions 

• clean affected area
• apply small amount not more than 3 times daily
• may be covered with a sterile bandage

STORAGE AND HANDLING

Other Information

• store at room temperature
• tamper evident sealed packets
• do not use any opened or torn packets

INACTIVE INGREDIENT

Inactive ingredients

Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate/PÉG-100 Stearate, Maltodextrin, Mineral Oil, Phenoxyethanol, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SAFLY BURN 
lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43473-039
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
WATER (UNII: 059QF0KO0R)
ALOE (UNII: V5VD430YW9)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
DISODIUM HEDTA (UNII: KME849MC7A)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
MINERAL OIL (UNII: T5L8T28FGP)
TRICLOSAN (UNII: 4NM5039Y5X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43473-039-01	0.9 g in 1 PACKET; Type 0: Not a Combination Product	05/17/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/17/2024

Labeler - Nantong Health & Beyond Hygienic Products Inc. (421280161)

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc.		421280161	manufacture(43473-039)