WHIPPED GEL- colloidal oatmeal gel

Whipped Gel by

Drug Labeling and Warnings

Whipped Gel by is a Otc medication manufactured, distributed, or labeled by OCEAN OLIVE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

OCEAN OLIVE

Whipped Gel

Nourishing Eczema Spot Treatment

Skin Protectant

Accepted National Eczema Association

1.7 oz / 50 ml

ACTIVE INGREDIENT

Colloidal Oatmeal 0.1%

PURPOSE

Skin Protectant

INDICATIONS & USAGE

temporarily protects and helps relieve minor skin irritation and itching due to eczema

WARNINGS

For external use only.

When using this product do not get into eyes.

Stop use and consult a doctor if

• conditions worsen
• 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.

DOSAGE & ADMINISTRATION

Directions apply as needed.

INACTIVE INGREDIENT

Water, Helianthus Annuus (Sunflower) Seed Oil, Propanediol, Cetearyl Olivate, Sorbitan Olivate, Butyspermum Parkii (Shea) Butter, Sodium Acrylates Copolymer, Glycerin, Inulin, Fucus Vesiculosis (Bladderwrack) Extract, Cetyl Palmitate, Sorbitan Palmitate, Lecithin, Allantoin, Xanthan Gum, Phenoxyethanol, Ethylhexylglycerin, Lactic Acid, Sclerotium Gum, Cyanocobalamin, Pullulan, Silica.

QUESTIONS

Questions or comments?

Call toll free 1-800-484-9354 M-F 8am-5pm CST

www.ocean-olive.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WHIPPED GEL 
colloidal oatmeal gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84293-010
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
FUCUS VESICULOSUS (UNII: 535G2ABX9M)
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
LACTIC ACID (UNII: 33X04XA5AT)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SHEA BUTTER (UNII: K49155WL9Y)
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)
INULIN (UNII: JOS53KRJ01)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
XANTHAN GUM (UNII: TTV12P4NEE)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
PULLULAN (UNII: 8ZQ0AYU1TT)
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALLANTOIN (UNII: 344S277G0Z)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CYANOCOBALAMIN (UNII: P6YC3EG204)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84293-010-02	1 in 1 BOX	09/15/2024
1	NDC: 84293-010-01	50 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	09/15/2024

Labeler - OCEAN OLIVE LLC (066802770)