FDA.reportPublic FDA data

INKED AFTERCARE TATTOO BALM

Manufacturer
Skinfix, Inc. | Canadian Custom Packaging Company
Effective date
2022-12-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:42:27

Label at a glance#

ProductINKED AFTERCARE TATTOO BALM
Active ingredientALLANTOIN
Label structure8 sections

Indications and uses

Temporarily protects MINOR: CUTS SCRAPES BURNS HELPS PREVENT AND TEMPORARILY PROTECTS AND HELPS RELIEVE CHAFED, CHAPPED OR CRACKED LIPS

Dosage and administration

APPLY AS NEEDED.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

ALLANTOIN 0.5%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects MINOR:

  • CUTS
  • SCRAPES
  • BURNS
  • HELPS PREVENT AND TEMPORARILY PROTECTS AND HELPS RELIEVE CHAFED, CHAPPED OR CRACKED LIPS

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

  • Avoid contact with eyes
OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

APPLY AS NEEDED.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Caprylic/capric triglyceride, prunus amygdalus dulcis (sweet almond) oil, butyrospermum parkii (shea) butter, simmondsia chinensis (jojoba) seed oil, tocopherol, citrus aurantium dulcis (orange) peel extract.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SF_Inked_2oz_US_V3SF_Inked_2oz_US_V3SF_Inked_2oz_US_V3SF_Inked_2oz_US_V3

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61328-30261328-302-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SHEA BUTTERK49155WL9YIACT
ALMOND OIL66YXD4DKO9IACT
JOJOBA OIL724GKU717MIACT
TOCOPHEROLR0ZB2556P8IACT
ORANGE PEELTI9T76XD44IACT
ALLANTOIN344S277G0ZACTIB

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
253e0b67-7574-456a-8e7e-70eddb9e77bdc08e8b52-4540-4223-9f7a-0ad0959bb26f2023-06-06WarningsExact identifier
spl set id: c08e8b52-4540-4223-9f7a-0ad0959bb26f

Reported adverse events (FAERS/openFDA)#

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