HYLANDS NATURALS ECZEMA CREAM- colloidal oatmeal cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)

Available from:

Hylands

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

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._
----------
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 [e-mail]
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: 60