XZM CARE- colloidal oatmeal cream
Lavior 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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Active ingredient

Colloidal Oatmeal 1%......................Skin Protectant

Purpose:

skin protectant

Uses:

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

Warnings

For external use only

When using this product

avoid contact with eyes

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.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply a thin layer 1 to 2 times daily, or as directed by a doctor
for babies under 2 months of age: ask a doctor

Other information

for mild to moderate eczema
store at room temperature

Inactive ingredients:

Aqua, Glycerin, Inula Viscosa Flower/Leaf/Stem Extract, Xanthan Gum, Glyceryl Stearate Citrate, Aloe Barbadensis Leaf Juice, Propanediol-1,3, Cetyl Alcohol, Sodium Benzoate, Potassium Sorbate, Biosaccharide Gum-1, Tocopheryl Acetate (Vitamin E), Sodium Gluconate, Citric Acid.

Questions?

Call toll free 1-844-474-2552 or visit lavior.com

XZM CARE

XZM CARE
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71521-678
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
XANTHAN GUM (UNII: TTV12P4NEE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DITTRICHIA VISCOSA WHOLE (UNII: 3SYW69FH88)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM GLUCONATE (UNII: R6Q3791S76)
PROPANEDIOL (UNII: 5965N8W85T)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71521-678-30	1 in 1 BOX	07/21/2017	06/01/2021
1		30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/21/2017	06/01/2021

Labeler - Lavior Inc. (080685327)

Revised: 6/2021

Document Id: c5482950-ae59-7653-e053-2995a90ad5d7

Set id: 5422fb7f-8dea-648b-e054-00144ff8d46c

Version: 8

Effective Time: 20210621

Lavior Inc.