KIDS ECZEMA BALM- skin protectant 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

COLLOIDAL OATMEAL 2%

PURPOSE

SKIN PROTECTANT

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

USES

TEMPORARILY PROTECTS AND HELPS RELIEVE MINOR SKIN IRRITATION AND ITCHING DUES 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.

DIRECTIONS

APPLY BALM LIBERALLY AS NEEDED, ESPECIALLY AFTER BATHING.

INACTIVE INGREDIENTS

ALLANTOIN, ALOE BARBADENSIS LEAF JUICE, BEESWAX, BUTYROSPERMUM PARKII (SHEA) BUTTER, COCOS NUCIFERA (COCONUT) OIL, HELIANTHUS ANNUUS (SUNFLOWER) OIL, PARAFFIN, PETROLATUM, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, ZINC OXIDE.

US_Kids_EczemaBalm_2oz

KIDS ECZEMA BALM
skin protectant ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61328-005
Route of Administration	TOPICAL

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)
PARAFFIN (UNII: I9O0E3H2ZE)
YELLOW WAX (UNII: 2ZA36H0S2V)
COCONUT OIL (UNII: Q9L0O73W7L)
SHEA BUTTER (UNII: K49155WL9Y)
ALMOND OIL (UNII: 66YXD4DKO9)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TOCOPHEROL (UNII: R0ZB2556P8)
ALLANTOIN (UNII: 344S277G0Z)
ZINC OXIDE (UNII: SOI2LOH54Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61328-005-01	60 g in 1 TUBE; Type 0: Not a Combination Product	04/09/2014	01/03/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	04/09/2014	01/03/2020

Labeler - Skinfix, Inc. (203158183)

Registrant - Skinfix, Inc. (203158183)

Revised: 1/2020

Document Id: f262e434-eec4-4c05-a078-631bc71735fb

Set id: eaccfe5b-3bf1-4fd6-a067-d9cbfc632dcf

Version: 3

Effective Time: 20200103

Skinfix, Inc.