Kids Eczema by Rosemont Ventures, Inc. / Monarch PCM, LLC Kids Eczema Cream 2 oz

Kids Eczema by

Drug Labeling and Warnings

Kids Eczema by is a Otc medication manufactured, distributed, or labeled by Rosemont Ventures, Inc., Monarch PCM, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KIDS ECZEMA- colloidal oatmeal cream 
Rosemont Ventures, Inc.

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Kids Eczema Cream 2 oz

Active Ingredient

Colloidal Oatmeal 1.0%

Purpose

Colloidal Oatmeal 1.0%..................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

• do not get into 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 as needed

Inactive Ingredients

Allantoin, Aloe Barbadensis (Aloe) Leaf Extract, Aqua (Water), Azadirachta Indica (Neem) Seed Oil, Bisabolol, Butyrospermum Parkii (Shea) Butter, Calcium Gluconate, Caprylic/Capric Triglyceride, Citric Acid, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Gluconolactone, Glycerin, Glyceryl Stearate SE, Kaolin, Potassium Sorbate, Sodium Benzoate, Squalane, Stearyl Alcohol, Xanthan Gum, Zea Mays (Corn) Starch†, Zinc Oxide

Questions or Comments?

Call (800) 246-7328or visit www.allterrainco.com

Effective, natural & safe

ALL TERRAIN

Kids Eczema Cream

Colloidal Oatmeal 1% Skin Protectant

Soothes, protects & relieves itching & irritation due to eczema

Made with 95+% naturally derived ingredients

2.0 FL. OZ. (59 mL)

KIDS ECZEMA 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82960-245
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 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
STARCH, CORN (UNII: O8232NY3SJ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALLANTOIN (UNII: 344S277G0Z)
AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)
LEVOMENOL (UNII: 24WE03BX2T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SHEA BUTTER (UNII: K49155WL9Y)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
XANTHAN GUM (UNII: TTV12P4NEE)
ZINC OXIDE (UNII: SOI2LOH54Z)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82960-245-01	1 in 1 CARTON	09/15/2022	12/21/2023
1		59 mL in 1 TUBE; 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	09/15/2022	12/21/2023

Labeler - Rosemont Ventures, Inc. (933509465)

Establishment
Name	Address	ID/FEI	Business Operations
Monarch PCM, LLC		080000294	manufacture(82960-245)

Revised: 12/2023

Document Id: 0d9a8769-874d-c4d8-e063-6394a90a6e10

34390-5

Set id: e932aa34-c460-b6ed-e053-2a95a90a2b3a

Version: 2

Effective Time: 20231228