AFTER BURN- 2.5% lidocaine hcl gel

After Burn by

Drug Labeling and Warnings

After Burn by is a Otc medication manufactured, distributed, or labeled by Tender Corporation d/b/a Adventure Ready Brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active Ingredient

Lidocaine Hydrochloride 2.50%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain due to minor burns, sunburns, minor cuts, scrapes, or minor skin irritations

Warnings

for external use only

When using this product

avoid contact with eyes

do not use in large quantities, particularly over raw surfaces or blistered areas

do not use longer than 1 week unless directed by doctor

Stop Use and ask a doctor if

Condition worsens

Symptoms persist for more than 7 days or clear

up and occur again within a few days.

Keep out of reach of children

if swallowed, get medical help or contact poisn control center right away.

If in eyes

flush with water for 15 minutes and call a doctor

Directions

Clean rg affected area.

Adults and children 2 years of age and older apply a small amount to affected area not more than 3 times daily.

Children under 2 years of age consult a doctor

Inactive Ingredients

Aloe Vera, Benzalkonium Chloride, Carbomer 980, GLycerol USP, Herbal Fragrance, Menthol, Polysorbate 20, Propylene Glycol, Purified Water, Sodium Hydroxide

Secondary Packaging After Burn Box

After Burn Primary Packaging Label

INGREDIENTS AND APPEARANCE

AFTER BURN 
2.5% lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44224-1220
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	1.425 g  in 57 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.14 g  in 57 g
WATER (UNII: 059QF0KO0R)	44.3 g  in 57 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)	0.0015 g  in 57 g
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	0.57 g  in 57 g
POLYSORBATE 20 (UNII: 7T1F30V5YH)	1.14 g  in 57 g
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.57 g  in 57 g
MENTHOL (UNII: L7T10EIP3A)	0.057 g  in 57 g
CARBOMER 980 (UNII: 4Q93RCW27E)	5.7 g  in 57 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	2.85 g  in 57 g
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)	4.56 g  in 57 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44224-1220-1	1 in 1 BOX	11/11/2024
1	NDC: 44224-1220-0	57 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	11/11/2024

Labeler - Tender Corporation d/b/a Adventure Ready Brands (064437304)

Registrant - Tender Corporation d/b/a Adventure Ready Brands (064437304)

Establishment
Name	Address	ID/FEI	Business Operations
Tender Corporation d/b/a Adventure Ready Brands		064437304	manufacture(44224-1220) , label(44224-1220) , pack(44224-1220)