INKED AFTERCARE TATTOO BALM- allantoin ointment

INKED AFTERCARE TATTOO BALM by

Drug Labeling and Warnings

INKED AFTERCARE TATTOO BALM by is a Otc medication manufactured, distributed, or labeled by Skinfix, Inc., Canadian Custom Packaging Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

ALLANTOIN 0.5%

Purpose

Skin protectant

Uses

Temporarily protects MINOR:

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

Warnings

For external use only

When using this product

• Avoid contact with eyes

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

KEEP OUT OF REACH OF CHILDREN

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

Directions

APPLY AS NEEDED.

Inactive Ingredients

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INKED AFTERCARE TATTOO BALM 
allantoin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SHEA BUTTER (UNII: K49155WL9Y)
ALMOND OIL (UNII: 66YXD4DKO9)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
ORANGE PEEL (UNII: TI9T76XD44)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61328-302-12	60 g in 1 TUBE; Type 0: Not a Combination Product	12/26/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/26/2018

Labeler - Skinfix, Inc. (203158183)

Registrant - Skinfix, Inc. (203158183)