ECZEMA RELIEF- colloidal oatmeal cream

ECZEMA RELIEF by

Drug Labeling and Warnings

ECZEMA RELIEF by is a Otc medication manufactured, distributed, or labeled by ACUTENS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Colloidal Oatmeal 1.00%

PURPOSE

SKIN PROTECTANT

USES

• temporarily protects and helps relieve minor skin irritation and itching due to:
• rashes
• eczema
• poison ivy, oak, or sumac
• insect bites

WARNINGS

• do not get into eyes.
• to avoid slipping, use mat in tub or shower.
• in some skin conditions, soaking too long may over dry.

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

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

PREGNANCY

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

DIRECTIONS

• apply as needed

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ECZEMA RELIEF 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80551-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80551-301-34	96 g in 1 TUBE; Type 0: Not a Combination Product	10/03/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/03/2021

Labeler - ACUTENS, INC. (051133165)