GENTLE ECZEMA BALM by Skinfix, Inc.

GENTLE ECZEMA BALM by

Drug Labeling and Warnings

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

Drug Details [pdf]

GENTLE ECZEMA BALM- colloidal 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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ACTIVE INGREDIENTS

COLLOIDAL OINTMENT 2%

PURPOSE

SKIN PROTECTANT

USES

TEMPORARILY PROTECTS AND HELPS RELIEVE MINOR SKIN IRRITATIONS 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 FOR 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 65-80°f. MAY STAIN FABRICS.

INACTIVE INGREDIENTS

ALLANTOIN, BEESWAX, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, PARAFFIN WAX, PETROLATUM, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, TOCOPHEROL, ZINC OXIDE.

GENTLE ECZEMA BALM 
colloidal oatmeal ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
ALMOND OIL (UNII: 66YXD4DKO9)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61328-104-12	60 g in 1 TUBE; Type 0: Not a Combination Product	12/09/2013	01/03/2020
2	NDC: 61328-104-14	120 g in 1 TUBE; Type 0: Not a Combination Product	12/09/2013	01/03/2020
3	NDC: 61328-104-97	7 g in 1 POUCH; Type 0: Not a Combination Product	09/27/2016	01/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/09/2013	01/03/2020

Labeler - Skinfix, Inc. (203158183)

Registrant - Skinfix, Inc. (203158183)

Revised: 1/2020

Document Id: 55059822-b703-4513-b068-c13beb365227

34390-5

Set id: 44e65571-d7ef-4b8b-a311-aa9e10ce7e17

Version: 3

Effective Time: 20200103