Babyganics® Eczema Lotion

Babyganics® Eczema Lotion
SPL v3
SPL
SPL Set ID cd062efe-f695-46bd-a89c-f2f6acf6e24a
Route
TOPICAL
Published
Effective Date 2018-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (10 mg)
Inactive Ingredients
Water Shea Butter Cetostearyl Alcohol Cetyl Alcohol Isopropyl Palmitate Glycerin Glyceryl Monostearate Cocoa Butter Oat Nigella Sativa Seed Oil Carrot Seed Oil Chia Seed Oil Raspberry Seed Oil Cranberry Seed Oil Cetearyl Glucoside Tocopherol Glyceryl Dilaurate Caprylyl Glycol Xanthan Gum Phytate Sodium Ethylhexylglycerin Citric Acid Monohydrate Sodium Hydroxymethylglycinate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-06-21

Description

Drug Facts

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Drug Facts

Uses

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

  • rashes
  • eczema
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50567-7

When using this product do not get into eyes

Warnings

For external use only

Directions
  • apply as needed
  • massage into baby's skin, especially after bathing - perfect for face and body
  • for use on mild to moderate eczema or as directed by a physician
Active Ingredient

Colloidal oatmeal 1%

Other Information

Store at room temperature 59-77°F (15-25°C)

Inactive Ingredients

water, butyrospermum parkii (shea) butter, cetearyl alcohol, cetyl alcohol, isopropyl palmitate, glycerin, glyceryl stearate, theobroma cacao (cocoa) seed butter, hydrolyzed oats, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil, rubus idaeus (red raspberry) seed oil, cetearyl glucoside, tocopherol, glyceryl dilaurate, caprylyl glycol, xanthan gum, sodium phytate, ethylhexylglycerin, citric acid, sodium hydroxymethylglycinate

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
Principal Display Panel 226 G Tube Label

extra

soothing

babyganics®

eczema care

skin protectant cream

with colloidal oatmeal ∙ relieves dry,

itchy, irritated skin ∙ non–allergenic

pediatrician & dermatologist tested

no: cortisone, steroids, parabens,

sulfates, phthalates or fragrances

+ NeoNourish® Natural

Seed Oil Blend

8 OZ (226g)


Structured Label Content

Uses

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

  • rashes
  • eczema
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product do not get into eyes

Purpose

Skin protectant

Warnings

For external use only

Directions
  • apply as needed
  • massage into baby's skin, especially after bathing - perfect for face and body
  • for use on mild to moderate eczema or as directed by a physician
Active Ingredient (Active ingredient)

Colloidal oatmeal 1%

Other Information (Other information)

Store at room temperature 59-77°F (15-25°C)

Inactive Ingredients (Inactive ingredients)

water, butyrospermum parkii (shea) butter, cetearyl alcohol, cetyl alcohol, isopropyl palmitate, glycerin, glyceryl stearate, theobroma cacao (cocoa) seed butter, hydrolyzed oats, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil, rubus idaeus (red raspberry) seed oil, cetearyl glucoside, tocopherol, glyceryl dilaurate, caprylyl glycol, xanthan gum, sodium phytate, ethylhexylglycerin, citric acid, sodium hydroxymethylglycinate

Stop Use and Ask A Doctor If (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
Principal Display Panel 226 G Tube Label (PRINCIPAL DISPLAY PANEL - 226 g Tube Label)

extra

soothing

babyganics®

eczema care

skin protectant cream

with colloidal oatmeal ∙ relieves dry,

itchy, irritated skin ∙ non–allergenic

pediatrician & dermatologist tested

no: cortisone, steroids, parabens,

sulfates, phthalates or fragrances

+ NeoNourish® Natural

Seed Oil Blend

8 OZ (226g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)