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NDC 65112-0269-01 Atopis Med 0.005 g/g Details

Atopis Med 0.005 g/g

Atopis Med is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by I Shay Cosmetics Inc. The primary component is OATMEAL.

Product Information

NDC	65112-0269
Product ID	65112-269_d2460d8e-1b53-6ffd-e053-2a95a90a468d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Atopis Med
Proprietary Name Suffix	n/a
Non-Proprietary Name	Eczema Cream
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	0.005
Active Ingredient Units	g/g
Substance Name	OATMEAL
Labeler Name	I Shay Cosmetics Inc
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2023-12-31

Package

Package Images

NDC 65112-0269-01 (65112026901)

Pricing Information	N/A
NDC Package Code	65112-269-01
Billing NDC	65112026901
Package	75 g in 1 TUBE (65112-269-01)
Marketing Start Date	2021-12-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d2460d8e-1b52-6ffd-e053-2a95a90a468d Details

Warnings

For external use only

When using this product for the first time

-do an allergy patch test

Stop use and ask a Doctor if

-condition worsens

Keep out of reach of children

Uses

temporarily protects and helps relieve minor skin irritation and itching due to rashes, eczema, insect bites

Indications & Usage Section

Uses temporarily protects and helpsrelieve minor skin irritation and itching due to rashes eczema insect bites

Directions Apply twice daily for best results

OTC Active Ingredient Section

Colloidal Oats 0.5%

Keep Out of Reach of Children

Keep out of reach of children.

Dosage & Administration

Apply twice daily for best results.

Inactive ingredients

Water, Myrecil, Olivem 1000, Cetearyl alcohol, Endmusol 20D, Macadamia oil, Safflower oil, Shea butter, glycerin, Harakeke gel, Geogard 221, Hyaluronic acid, Lavender oil, Tocopherol acetate, Manuka oil, Manuka honey, Citric acid, Xantham gum

box

INGREDIENTS AND APPEARANCE

ATOPIS MED

eczema cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65112-269
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.005 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	0.676 g in 1 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65112-269-01	75 g in 1 TUBE; Type 0: Not a Combination Product	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	12/31/2021

Labeler - I Shay Cosmetics Inc (151582384)

Revised: 12/2021

Document Id: d2460d8e-1b53-6ffd-e053-2a95a90a468d

Set id: d2460d8e-1b52-6ffd-e053-2a95a90a468d

Version: 1

Effective Time: 20211203