Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID da3a39d7-197f-4451-9d24-f92adbe0fc19
Route
TOPICAL
Published
Effective Date 2024-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (2 g)
Inactive Ingredients
Aloe Vera Leaf Shea Butter Carbomer Homopolymer, Unspecified Type Cetyl Alcohol Coconut Oil Dimethicone Edetate Disodium Ethylhexylglycerin Glyceryl Monostearate Hydrogenated Soybean Lecithin Isopropyl Palmitate Peg-40 Monostearate Petrolatum Phenoxyethanol Sodium Hydroxide Steareth-2 Stearic Acid Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01

Description

Active ingredient Purpose Colloidal oatmeal 2.0% Skin protectant


Medication Information

Warnings and Precautions

Warnings

For external use only

Description

Active ingredient Purpose Colloidal oatmeal 2.0% Skin protectant

Uses
  • temporarily protects and helps relieve minor skin irritation and itching due to:
    • eczema
    • rashes
Section 50565-1

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 53413-1

Questions or comments?

1-800-824-4894

Section 55105-1
Active ingredient Purpose
Colloidal oatmeal 2.0% Skin protectant
Directions
  • apply to affected areas of skin as needed
Other Information
  • store product at 20-25°C (68-77°F)
  • for mild to moderate eczema or as directed by a doctor
  • keep carton for full product information.
Inactive Ingredients

aloe barbadensis leaf juice, butyrospermum parksii (shea)

butter, carbomer, cetyl alcohol, cocos nucifera (coconut) oil,

dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl

stearate, hydrogenated lecithin, isopropyl palmitate, PEG-40

stearate, petrolatum, phenoxyethanol, sodium hydroxide,

steareth-2, stearic acid, water, xanthan gum.



Principal Display Panel

New



Nizoral®




Eczema

Relief Cream




COLLOIDAL OATMEAL 2%

SKIN PROTECTANT



For Eczema Prone Skin




RELIEVES

Dry, Itchy Irritated Skin



SOOTHES & HYDRATES

with Shea Butter & Aloe



PROECTS

Skin from Itching

& Irritation



HELPS STRENGTHEN

Skin Moisture Barrier



Free of Fragrance,

Steroids & Parabens



Net wt 4 oz (113 g)



Specially 

formulated with:



√ Shea Butter

√ Aloe



Free of:



 Steroids

Fragrances

Parabens



Before use, read all label

information. If you have

a drug reaction, contact

a doctor and report it by

calling:



1.800.824.4894



Distributed by:

Kramer Laboratories, Inc.

Bridgewater, NJ 08807 

USA



© 2024 KRAMER

LABORATORIES, INC.



K0724

When Using This Product
  • avoid contact with the eyes
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days


Structured Label Content

Uses
  • temporarily protects and helps relieve minor skin irritation and itching due to:
    • eczema
    • rashes
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 53413-1 (53413-1)

Questions or comments?

1-800-824-4894

Section 55105-1 (55105-1)
Active ingredient Purpose
Colloidal oatmeal 2.0% Skin protectant
Directions
  • apply to affected areas of skin as needed
Other Information (Other information)
  • store product at 20-25°C (68-77°F)
  • for mild to moderate eczema or as directed by a doctor
  • keep carton for full product information.
Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, butyrospermum parksii (shea)

butter, carbomer, cetyl alcohol, cocos nucifera (coconut) oil,

dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl

stearate, hydrogenated lecithin, isopropyl palmitate, PEG-40

stearate, petrolatum, phenoxyethanol, sodium hydroxide,

steareth-2, stearic acid, water, xanthan gum.



Principal Display Panel (PRINCIPAL DISPLAY PANEL)

New



Nizoral®




Eczema

Relief Cream




COLLOIDAL OATMEAL 2%

SKIN PROTECTANT



For Eczema Prone Skin




RELIEVES

Dry, Itchy Irritated Skin



SOOTHES & HYDRATES

with Shea Butter & Aloe



PROECTS

Skin from Itching

& Irritation



HELPS STRENGTHEN

Skin Moisture Barrier



Free of Fragrance,

Steroids & Parabens



Net wt 4 oz (113 g)



Specially 

formulated with:



√ Shea Butter

√ Aloe



Free of:



 Steroids

Fragrances

Parabens



Before use, read all label

information. If you have

a drug reaction, contact

a doctor and report it by

calling:



1.800.824.4894



Distributed by:

Kramer Laboratories, Inc.

Bridgewater, NJ 08807 

USA



© 2024 KRAMER

LABORATORIES, INC.



K0724

When Using This Product (When using this product)
  • avoid contact with the eyes
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days


Advanced Ingredient Data


Raw Label Data

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