ECZEMA RELIEF- colloidal oatmeal cream 
ACUTENS, 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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ACUTENS - KANJO - NATURAL ECZEMA RELIEF CREAM

ACTIVE INGREDIENTS

Colloidal Oatmeal 1.00%

PURPOSE

SKIN PROTECTANT

USES

WARNINGS

STOP USE AND ASK A DOCTOR IF

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help, or contact a Poison Control Center right away.

IF PREGNANT OR BREAST-FEEDING, ask a health professional before use

DIRECTIONS

INACTIVE INGREDIENTS

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Bisabalol, Beeswax, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oil, Ceramide NG, Chamomilla Matricaria (Chamomile) Extract, Cucumis Sativus (Cucumber) Extract, Emu Oil, Glucosamine Sulfate, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus
(Sunflower) Oil, Punica Granatum (Pomegranate) Extract, Xanthan Gum.

OTHER INFORMATION

Protect the product in this container from excessive heat and direct sun.

QUESTIONS?

(917) 745-3082

01b LBL_EczemaCreamLabel

ECZEMA RELIEF 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80551-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SHEA BUTTER (UNII: K49155WL9Y)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
CHAMOMILE (UNII: FGL3685T2X)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CUCUMBER (UNII: YY7C30VXJT)  
EMU OIL (UNII: 344821WD61)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
LICORICE (UNII: 61ZBX54883)  
POMEGRANATE (UNII: 56687D1Z4D)  
CERAMIDE NG (UNII: C04977SRJ5)  
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80551-301-3496 g in 1 TUBE; Type 0: Not a Combination Product10/03/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/03/2021
Labeler - ACUTENS, INC. (051133165)

Revised: 9/2023
Document Id: 0632749f-b226-4d27-e063-6294a90a9ed7
Set id: cd79a848-938a-18e2-e053-2a95a90a1a30
Version: 4
Effective Time: 20230925
 
ACUTENS, INC.