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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SKINFIX - ECZEMA BALM (61328-109)

Active Ingredient

Colloidal Oatmeal  2%

Purpose

Skin protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rash and 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 a Poison Control Center right away

Directions

Apply generously to affected areas, especially after bathing.

Other information

Store at 65-80°F. May stain fabrics. For adults and children two year of age and older

Inactive Ingredients

allantoin, beeswax, butyrospermum parkii (shea) butter, glycine soja (soybean) oil, paraffin wax, petrolatum, petrolatum, prunus amygdalus dulcis (sweet almond) oil, simmondsia chinensis (jojoba) seed oil, tocopherol, zinc oxide.

US_EczemaBalm_Tube2oz_V6_OL_R

ECZEMA BALM 
oatmeal ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61328-109-1260 mL in 1 TUBE; Type 0: Not a Combination Product12/09/2013
2NDC:61328-109-1130 mL in 1 TUBE; Type 0: Not a Combination Product12/09/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/09/201303/15/2017
Labeler - Skinfix, Inc. (203158183)

Revised: 11/2021
Document Id: d10741ee-ccdf-f239-e053-2995a90a963f
Set id: ac7eb856-201e-4e76-8cbd-4a9983dd6713
Version: 4
Effective Time: 20211117
 
Skinfix, Inc.