SKINFIX HAND REPAIR- 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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SKINFIX - HAND REPAIR CREAM (61328-106)

Active Ingredients

Colloidal Oatmeal 1%

Purpose

Skin Protectant

Warnings

For external use only.

When using this product Avoid contact with eyes.

Stop use and ask a doctor if condition worsens.

If 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.

Uses

Temporarily protects dry cracked skin and helps relieve monor skin irritations and itching due to eczema.

Directions

Apply cream liberally as needed, especially after hand washing.

Inactive Ingredients:

allantoin, aloe barbadensis leaf juice, avena sativa kernel oil, beeswax, butyrospermum parkii (shea) butter, calendula officinalis extract, capyrlic/capric triglyceride, caprylyl-caprylate/caprate, chamomilla recutita (matricaria) flower extract, citric acid, ethylhexylglycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, oryza sativa (rice) bran extract, petrolatum, phenoxyethanol, polyglyceryl-2-stearate, potassium sorbate, prunus amygdalus dulcis (sweet almond) oil, rosmarinus officinalis (rosemary) leaf extract, simmondsia chinensis (jojoba) seed oil, stearyl alcohol, tocopherol, trisodium ethylenediamine disuccinate, water (aqua), xanthan gum

30 ml

Skinfix_Hand_Repair_Cream_v8_30.jpg

90 ml

Skinfix_Hand_Repair_Cream_v8_90.jpg

SKINFIX HAND REPAIR 
oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
OAT KERNEL OIL (UNII: 3UVP41R77R)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SHEA BUTTER (UNII: K49155WL9Y)  
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)  
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)  
JOJOBA OIL (UNII: 724GKU717M)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61328-106-1390 mL in 1 TUBE; Type 0: Not a Combination Product07/02/2014
2NDC:61328-106-1130 mL in 1 TUBE; Type 0: Not a Combination Product09/23/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/02/2014
Labeler - Skinfix, Inc. (203158183)
Registrant - Skinfix, Inc. (203158183)
Establishment
NameAddressID/FEIBusiness Operations
SIGAN INDUSTRIES INC255106239manufacture(61328-106)

Revised: 12/2022
Document Id: aa4f4099-06db-400a-95d3-b9ecec6bbf7d
Set id: 1b65fc81-1b9e-4260-829a-332cf6891d02
Version: 8
Effective Time: 20221224
 
Skinfix, Inc.