AFTER BURN- lidocaine hydrochloride gel 
Adventure Ready Brands

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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After Burn

Active Ingredient

Lidocaine Hydrochloride 2.50%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain due to minor burns, sunburn, minor cuts, screapes or minor skin irritations

Warnings

For external use only.

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

If in eyes, flush with water for 15 minutes and call a doctor.

Directions

Clean affected area

Adults and Children 2 years and older apply small amount to affected area not more than 3 times daily

Children under 2 years consult a doctor.

Inactive Ingredients

Aloe Vera gel, benzalkonium chloride, carbomer 980, glycerol USP, herbal fragrance, menthol, polysorbate 20, propylene glycol, purified water, and sodium hydroxide (50%)

After Burn

Box

AFTER BURN 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90107-5120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:90107-5120-11 in 1 BOX09/01/2020
159 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:90107-5120-0118 mL in 1 TUBE; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/2020
Labeler - Adventure Ready Brands (064437304)
Registrant - Adventure Ready Brands (064437304)
Establishment
NameAddressID/FEIBusiness Operations
Adventure Ready Brands064437304manufacture(90107-5120)

Revised: 9/2020
Document Id: afd5040e-40ef-2cc1-e053-2a95a90a4e7b
Set id: afd4fbe8-2b5d-300e-e053-2995a90a0c65
Version: 1
Effective Time: 20200921
 
Adventure Ready Brands