INKED by Skinfix, Inc.

INKED by

Drug Labeling and Warnings

INKED by is a Otc medication manufactured, distributed, or labeled by Skinfix, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INKED- allantoin ointment 
Skinfix, Inc.

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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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. 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.

SF_Inked_2oz_US_V3

INKED 
allantoin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61328-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61328-301-1260 g in 1 TUBE; Type 0: Not a Combination Product05/23/201501/03/2020
2NDC: 61328-301-055 g in 1 POUCH; Type 0: Not a Combination Product03/15/201701/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/23/201501/03/2020
Labeler - Skinfix, Inc. (203158183)
Registrant - Skinfix, Inc. (203158183)

Revised: 1/2020
Document Id: 7caa36a3-1353-4793-b840-93484127dde1
Set id: 35bba20d-2c75-4ba6-9048-42af3a1ae4b0
Version: 3
Effective Time: 20200103
 
Skinfix, Inc.