EXTRA STRENGTH BODY- colloidal oatmeal cream 
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 Oatmeal 2%

Purpose

Skin protectant

Uses

Temporarily protects and helps relieve minor skin irritations 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

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.

Inactive Ingredients

Water/Eau/Aqua, Glycerin, Caprylic/Capric Triglyceride, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Stearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Polyglyceryl-2 Stearate, Caprylyl Caprylate/Caprate, Glyceryl Stearate, Vitis Vinifera (Grape) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Phenoxyethanol, Oryza Sativa (Rice) Bran Extract, Avena Sativa (Oat) Kernel Oil, Allantoin, Xanthan Gum, Avena Sativa (Oat) Bran Extract, Potassium Sorbate, Citric Acid, Rosmarinus Officinalis (Rosemary) Leaf Extract, Ethylhexylglycerin, Moringa Oil/Hydrogenated Moringa Oil Esters, Simmondsia Chinensis (Jojoba) Seed Oil, Trisodium Ethylenediamine Disuccinate, Aloe Barbadensis Leaf Juice, Tocopherol, Helianthus Annuus (Sunflower) Extract.

Principal Display Panel

61328-119-28v2-R261328-119-28v2-R2

EXTRA STRENGTH BODY 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-119
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)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
OAT KERNEL OIL (UNII: 3UVP41R77R)  
SHEA BUTTER (UNII: K49155WL9Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
RICE BRAN (UNII: R60QEP13IC)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ALMOND OIL (UNII: 66YXD4DKO9)  
ROSEMARY (UNII: IJ67X351P9)  
JOJOBA OIL (UNII: 724GKU717M)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61328-119-28236 mL in 1 TUBE; Type 0: Not a Combination Product01/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/30/2022
Labeler - Skinfix, Inc. (203158183)
Registrant - Skinfix, Inc. (203158183)
Establishment
NameAddressID/FEIBusiness Operations
Canadian Custom Packaging Company207062514manufacture(61328-119)

Revised: 1/2022
Document Id: b707b1b5-c318-40e2-82c8-530d851f02a4
Set id: 32ba5f29-c037-44dd-b5b1-59001ac50753
Version: 5
Effective Time: 20220130
 
Skinfix, Inc.