GENTLE ECZEMA BALM- oatmeal 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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Gentle Eczema Balm

Active Ingredient

Colloidal Oatmeal 2%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to . eczema . rash . dermatitis

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 Poison Control Center right away.

Directions

Apply balm liberally as needed, especially after bathing

Other Information

Store at 65-80deg F . May stain fabrics

Inactive Ingredients

allantoin, beeswax, helianthus annuus (sunflower) oil, paraffin, petrolatum, simmondsia chinensis (jojoba) seed oil, tocopherol, zinc oxide

GEB 60g label

GENTLE ECZEMA BALM
skin protectant ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61328-008
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	.02 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
ZINC OXIDE (UNII: SOI2LOH54Z)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
WHITE WAX (UNII: 7G1J5DA97F)
PARAFFIN (UNII: I9O0E3H2ZE)
ALLANTOIN (UNII: 344S277G0Z)
SUNFLOWER OIL (UNII: 3W1JG795YI)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61328-008-01	60 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	12/09/2013	02/23/2016

Labeler - Skinfix, Inc. (203158183)

Registrant - Product Integrity Laboratory, LLC (783863694)

Name	Address	ID/FEI	Business Operations
Establishment
Canadian Custom Packaging Company		207062514	manufacture(61328-008)

Revised: 2/2016

Document Id: c146ac6d-0a82-4e2f-a842-9a72052ff6a1

Set id: e87f6b23-f2e9-4bf6-80f1-57711996f15a

Version: 2

Effective Time: 20160223

Skinfix, Inc.