eczema dermatitis relief balm

eczema dermatitis relief balm
SPL v4
SPL
SPL Set ID fb801d20-9bec-1c71-e053-6394a90a6e95
Route
topical
Published
Effective Date 2023-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
oatmeal (5 g)
Inactive Ingredients
sodium citrate polyhydroxystearic acid (2300 mw) amylopectin, unspecified source phenylpropanol phytosteryl macadamiate potassium sorbate sodium chloride sodium carbonate sodium benzoate macadamia seed oil glycereth-8 esters hexylene glycol lecithin, soybean glycerin glyceryl monostearate shea butter helianthus annuus seed wax pentylene glycol phytosphingosine hyaluronate sodium tocopherol phymatolithon calcareum cetostearyl alcohol coco-caprylate/caprate sorbitan olivate octyldodecanol squalane sodium stearoyl glutamate zinc oxide sodium lauroyl lactylate medium-chain triglycerides sodium hydroxide propanediol castanea sativa leaf sodium copper chlorophyllin sodium dehydroacetate hexapeptide-11 lactic acid ceramide 1 water triheptanoin allantoin squalene caprylyl glycol cholesterol xanthan gum ethylhexylglycerin cetearyl olivate sunflower oil phenoxyethanol carbomer homopolymer, unspecified type aceglutamide ceramide np ceramide ap folic acid citric acid monohydrate cherimoya

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
otc monograph drug active Since 2023-10-01

Purpose

Skin protectant

Description

Colloidal Oatmeal 5%


Medication Information

Warnings

For external use only.

When using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water.

Uses

Temporarily protects and helps relieve minor skin irritations and itching due to rashes or eczema.

Purpose

Skin protectant

Directions

Apply as needed to face and body.

Inactive Ingredients

Water/Aqua/Eau, Glycerin, Annona Cherimola Fruit Extract, Jojoba Oil/Macadamia Seed Oil Esters, Cetearyl Alcohol, Glyceryl Stearate, Cetearyl Olivate, Coco-Caprylate/Caprate, Sorbitan Olivate, Squalane, Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum Parkii (Shea) Butter, Octyldodecanol, Triheptanoin, Allantoin, Zinc Oxide, Squalene, Helianthus Annuus (Sunflower) Seed Wax, Phytosteryl Macadamiate, Phytosterols, Lecithin, Acetyl Glutamine, Castanea Sativa (Chestnut) Leaf Extract, Ceramide NP, Amylopectin, Chlorophyllin-Copper Complex, Phytosphingosine, Ceramide AP, Cholesterol, Folic Acid, Hexapeptide-11, Oligopeptide-1, Oligopeptide-2, Bacillus/Soybean Ferment Extract, Sodium Hyaluronate, Oligopeptide-3, Tocopherol, Lithothamnion Calcareum Extract, Ceramide EOP, Carbomer, Sodium Stearoyl Glutamate, C9-12 Alkane, Polyurethane-100, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Caprylic/Capric Triglyceride, Sodium Lauroyl Lactylate, Sodium Hydroxide, Sodium Citrate, Propanediol, Polyhydroxystearic Acid, Pentylene Glycol, Sodium Dehydroacetate, Phenylpropanol, Citric Acid, Xanthan Gum, Lactic Acid, Sodium Carbonate, Sodium Chloride, Potassium Sorbate, Sodium Benzoate, Phenoxyethanol.

Description

Colloidal Oatmeal 5%

Questions?

1.866.927.2783

Section 51945-4

Active Ingredient

Colloidal Oatmeal 5%

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.


Structured Label Content

Warnings (WARNINGS)

For external use only.

When using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water.

Uses (USES)

Temporarily protects and helps relieve minor skin irritations and itching due to rashes or eczema.

Purpose (PURPOSE)

Skin protectant

Directions (DIRECTIONS)

Apply as needed to face and body.

Inactive Ingredients (INACTIVE INGREDIENTS)

Water/Aqua/Eau, Glycerin, Annona Cherimola Fruit Extract, Jojoba Oil/Macadamia Seed Oil Esters, Cetearyl Alcohol, Glyceryl Stearate, Cetearyl Olivate, Coco-Caprylate/Caprate, Sorbitan Olivate, Squalane, Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum Parkii (Shea) Butter, Octyldodecanol, Triheptanoin, Allantoin, Zinc Oxide, Squalene, Helianthus Annuus (Sunflower) Seed Wax, Phytosteryl Macadamiate, Phytosterols, Lecithin, Acetyl Glutamine, Castanea Sativa (Chestnut) Leaf Extract, Ceramide NP, Amylopectin, Chlorophyllin-Copper Complex, Phytosphingosine, Ceramide AP, Cholesterol, Folic Acid, Hexapeptide-11, Oligopeptide-1, Oligopeptide-2, Bacillus/Soybean Ferment Extract, Sodium Hyaluronate, Oligopeptide-3, Tocopherol, Lithothamnion Calcareum Extract, Ceramide EOP, Carbomer, Sodium Stearoyl Glutamate, C9-12 Alkane, Polyurethane-100, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Caprylic/Capric Triglyceride, Sodium Lauroyl Lactylate, Sodium Hydroxide, Sodium Citrate, Propanediol, Polyhydroxystearic Acid, Pentylene Glycol, Sodium Dehydroacetate, Phenylpropanol, Citric Acid, Xanthan Gum, Lactic Acid, Sodium Carbonate, Sodium Chloride, Potassium Sorbate, Sodium Benzoate, Phenoxyethanol.

Questions? (QUESTIONS?)

1.866.927.2783

Section 51945-4 (51945-4)

Active Ingredient (ACTIVE INGREDIENT)

Colloidal Oatmeal 5%

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
Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If swallowed get medical help or contact a poison control center right away.


Advanced Ingredient Data


Raw Label Data

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