84844-014

84844-014
SPL v1
SPL
SPL Set ID 26ed2b58-1291-05c8-e063-6394a90a7c8c
Route
TOPICAL
Published
Effective Date 2024-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Colloidal Oatmeal Extract (2 g)
Inactive Ingredients
Centella Asiatica Glycerin Carbomer Homopolymer, Unspecified Type Matrine Borneol Trolamine Gentiana Acaulis Whole Aloe Sodium Hyaluronate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-15

Description

Colloidal Oatmeal 2%

Purpose

Moisturizes and soothes the skin, promoting healing effects.


Medication Information

Purpose

Moisturizes and soothes the skin, promoting healing effects.

Description

Colloidal Oatmeal 2%

Use

•Temporarily protects and helps relieve minor skin irritation and itching due to newly tattooed skin

• Helps to moisturize skin and relieve dryness

• Helps to protect newly tattooed skin ..

Stop Use

Stop use and ask a doctor if condition worsens or if symptoms last more than 7 days or clearup and occur again within a few days.

Warnings

• For external use only.

• When using this product, avoid contact with eyes.

Ask Doctor

Stop use and ask a doctor if condition worsens or if symptoms last more than 7 days or clearup and occur again within a few days.

Directions

• Gently clean around the affected area.

• Apply a moderate amount of gel directly onto the affected area.

• Apply as needed.

Do Not Use

•Deep or puncture wounds. Animal bites. Serious burns.

When Using

•For external use only

•Do not get into eyes

•People with sensitive skin may feel a burning sensation forthe first few days after receiving a new tattoo.

Active Ingredient

Colloidal Oatmeal 2%

Other Information

• Store at 59 to 86 °F (15 to 30 °C).

Inactive Ingredients

Carbomer Homopolymer Trolamine、Gentiana Acaulis Whole、Matrine、Centella Asiatica、Aloe、Sodium Hyaluronate、Glycerol、Borneol

Principal Display Panel

Keep Oot of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

•Temporarily protects and helps relieve minor skin irritation and itching due to newly tattooed skin

• Helps to moisturize skin and relieve dryness

• Helps to protect newly tattooed skin ..

Purpose

Moisturizes and soothes the skin, promoting healing effects.

Stop Use

Stop use and ask a doctor if condition worsens or if symptoms last more than 7 days or clearup and occur again within a few days.

Warnings

• For external use only.

• When using this product, avoid contact with eyes.

Ask Doctor

Stop use and ask a doctor if condition worsens or if symptoms last more than 7 days or clearup and occur again within a few days.

Directions

• Gently clean around the affected area.

• Apply a moderate amount of gel directly onto the affected area.

• Apply as needed.

Do Not Use (Do not use)

•Deep or puncture wounds. Animal bites. Serious burns.

When Using

•For external use only

•Do not get into eyes

•People with sensitive skin may feel a burning sensation forthe first few days after receiving a new tattoo.

Active Ingredient

Colloidal Oatmeal 2%

Other Information (Other information)

• Store at 59 to 86 °F (15 to 30 °C).

Inactive Ingredients (Inactive ingredients)

Carbomer Homopolymer Trolamine、Gentiana Acaulis Whole、Matrine、Centella Asiatica、Aloe、Sodium Hyaluronate、Glycerol、Borneol

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)