FDA.reportPublic FDA data

After Burn

Manufacturer
Adventure Ready Brands
Effective date
2020-09-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:14:49

Label at a glance#

ProductAfter Burn
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 2.50%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • 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 a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

After Burn

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
90107-5120-02024-12-27C16284748780-1d6a99b39-b0c6-a426-e053-dadaa90af4c2After Burn
90107-5120-12024-12-27C16284748780-1d6a99b39-b0c6-a426-e053-dadaa90af4c2After Burn
90107-5120-02022-01-28C16284748780-1d6a99b39-b0c6-a426-e053-dadaa90af4c2After Burn
90107-5120-12022-01-28C16284748780-1d6a99b39-b0c6-a426-e053-dadaa90af4c2After Burn

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
90107-512090107-5120-1, 90107-5120-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2a462e60-6356-f791-e063-6294a90a62e3afd4fbe8-2b5d-300e-e053-2995a90a0c652024-12-27WarningsExact identifier
spl set id: afd4fbe8-2b5d-300e-e053-2995a90a0c65

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.