Hylands Naturals Eczema Cream

Hylands Naturals Eczema Cream by

Drug Labeling and Warnings

Hylands Naturals Eczema Cream by is a Otc medication manufactured, distributed, or labeled by Hylands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HYLANDS NATURALS ECZEMA CREAM- colloidal oatmeal cream 
Hylands

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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Hylands Naturals Eczema Cream

Drug Facts

Active ingredients
Colloidal Oatmeal 1%

Purpose
Skin protectant

Uses
Temporarily protects and helps relieve minor skin irritation and itching due to: ■ eczema  ■ rashes

Warnings
For external use only. When using this product do not get into eyes
Stop use and ask doctor if ■ condition worsens, ■ symptoms last
for 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 as needed.

Inactive ingredients  Water, Glycerin, Dicapryl Carbonate,
Glyceryl Stearate Citrate, Cetearyl Olivate, Sorbitan Olivate, Cetyl

Alcohol, Lauryl Laurate, Shea Butter, Cocoa Seed Butter, Benzyl

Alcohol, Dehydroacetic Acid, Xanthan Gum, Linseed Oil, Oat,

Organic Sunflower Seed Oil, Organic Lavender Flower Extract,

Organic Calendula Officianalis Flower Extract, Organic Aloe Leaf

Juice, Hydrolized Quinoa, Pantenol, Citric Acid.

Questions? www.hylands.com
or care@hylands.com

Package Labeling

Hylands

NATURALS

baby

ECZEMA
CREAM

DERMATOLOGIST TESTED

NET WT. 5 OZ. (142g)

DO NOT USE IF TAMPER-EVIDENT SEALIS BROKEN OR MISSING.

Manufactured for: Hyland’s, Inc., PO Box 61067, Los Angeles, CA 90061
www.hylands.com | REV001

res

HYLANDS NATURALS ECZEMA CREAM 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-4102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CETYL ALCOHOL (UNII: 936JST6JCN)
LAURYL LAURATE (UNII: GPW77G0937)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
XANTHAN GUM (UNII: TTV12P4NEE)
LINSEED OIL (UNII: 84XB4DV00W)
OAT (UNII: Z6J799EAJK)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)
PANTHENOL (UNII: WV9CM0O67Z)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-4102-1	142 g in 1 TUBE; Type 0: Not a Combination Product	12/05/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/05/2022	12/31/2023

Labeler - Hylands (008316655)

Revised: 1/2023

Document Id: d16c6a7f-2c68-4e35-aae4-a45c9c2cc3c5

34390-5

Set id: ff0c7f17-400c-4312-ac14-d1336b5dc653

Version: 4

Effective Time: 20230103