FIRST AID ONLY BURN- lidocaine hydrochloride gel

First Aid Only Burn by

Drug Labeling and Warnings

First Aid Only Burn by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine Hydrochloride 2%

PURPOSE

External Analgesic

USES

Temporarily relieves pain associated with minor burns

WARNINGS

For external use only.

Avoid contact with eyes

Do not use

▪ in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

▪condition worsens

▪symptoms persist for more than 7 days

▪symptoms clear up and occur again in a few days

Keep out of reach of children.

. If swallowed get medical help or contact Poison Control immediately

DIRECTIONS

Adults and children 2 years and over:

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

INACTIVE INGREDIENTS

Acrylates/C10-30 alkyl acrylate crosspolymer, Carbomer, Glycerin, Imidazolidinyl urea, Methylparaben, Propylparaben, Propylene Glycol, Purified water, Tea Tree Leaf Oil, Triethanolamine.

SPL UNCLASSIFIED SECTION

QUESTIONS 800-835-2263

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIRST AID ONLY BURN 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-5010(NDC:50382-020)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TEA TREE OIL (UNII: VIF565UC2G)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
IMIDUREA (UNII: M629807ATL)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-5010-01	6 in 1 CARTON	01/02/2020
1		3.5 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0924-5010-02	25 in 1 CARTON	01/02/2020
2		3.5 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 0924-5010-00	3.5 g in 1 PACKET; Type 0: Not a Combination Product	01/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/02/2020

Labeler - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	relabel(0924-5010) , repack(0924-5010)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		080119599	relabel(0924-5010) , repack(0924-5010)