First Aid Beauty Fab Ultra Repair Cream Skin Protectant

First Aid Beauty Fab Ultra Repair Cream Skin Protectant
SPL v1
SPL
SPL Set ID bec2f702-5ff5-ea66-e053-2a95a90ad1ec
Route
TOPICAL
Published
Effective Date 2021-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (0.5 g)
Inactive Ingredients
Ceramide Np Cetearyl Alcohol Eucalyptus Globulus Leaf Oil Squalane Tetrasodium Edta Glyceryl Stearate Se C12-15 Alkyl Benzoate Camellia Sinensis Leaf Caprylyl Glycol Tanacetum Parthenium Flower Sodium Hydroxide Phenoxyethanol Butyrospermum Parkii (shea) Butter Glycyrrhiza Glabra (licorice) Root Water Glycerin Allantoin Glyceryl Stearate Xanthan Gum Caprylic/capric Triglyceride Stearic Acid Mentha Aquatica Var. Citrata Leaf Mentha Piperita (peppermint) Oil Mentha Arvensis Leaf Oil Spearmint Oil Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-01

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 eczema, rashes, poison ivy, oak or sumac, insect bites
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 50566-9

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

Section 50567-7

Do not get into eyes.

Section 51727-6

Water, stearic acid, glycerin, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, glyceryl stearate SE, cetearyl alcohol, butyrospermum parkii (shea) butter, dimethicone, squalane, phenoxyethanol, caprylyl glycol, xanthan gum, allantoin, sodium hydroxide, mentha arvensis (cornmint) oil, tetrasodium EDTA, mentha spicata (spearmint) leaf oil, chrysanthemum parthenium (feverfew) extract, eucalyptus globulus leaf oil, mentha piperita (peppermint) oil, camellia sinensis leaf extract, glycyrrhiza glabra (licorice) root extract, mentha citrata bergamot mint, ceramide NP,.

Warnings

For external use only.

Directions

Apply as needed

Questions:

888-FAB-3063

Active Ingredients

Colloidal Oatmeal 0.5%

Principal Display Panel 56.7 G Tube

First Aid Beauty

FAB

Ultra Repair Cream

Intense Hydration

Skin Protectant Colloidal Oatmeal

FIrst Aid Beauty ®

Net Wt. 2.0 oz (56.7 g)


Structured Label Content

Uses
  • Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, poison ivy, oak or sumac, insect bites
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 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

Do not get into eyes.

Section 51727-6 (51727-6)

Water, stearic acid, glycerin, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, glyceryl stearate SE, cetearyl alcohol, butyrospermum parkii (shea) butter, dimethicone, squalane, phenoxyethanol, caprylyl glycol, xanthan gum, allantoin, sodium hydroxide, mentha arvensis (cornmint) oil, tetrasodium EDTA, mentha spicata (spearmint) leaf oil, chrysanthemum parthenium (feverfew) extract, eucalyptus globulus leaf oil, mentha piperita (peppermint) oil, camellia sinensis leaf extract, glycyrrhiza glabra (licorice) root extract, mentha citrata bergamot mint, ceramide NP,.

Purpose

Skin Protectant

Warnings

For external use only.

Directions

Apply as needed

Questions:

888-FAB-3063

Active Ingredients (Active ingredients)

Colloidal Oatmeal 0.5%

Principal Display Panel 56.7 G Tube (PRINCIPAL DISPLAY PANEL - 56.7 g tube)

First Aid Beauty

FAB

Ultra Repair Cream

Intense Hydration

Skin Protectant Colloidal Oatmeal

FIrst Aid Beauty ®

Net Wt. 2.0 oz (56.7 g)


Advanced Ingredient Data


Raw Label Data

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