43116-037

43116-037
SPL v3
SPL
SPL Set ID 2a373589-aec3-b294-e063-6394a90a39f1
Route
TOPICAL
Published
Effective Date 2024-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bicarbonate Ion (0.7 U)
Inactive Ingredients
Mentha Arvensis Flowering Top Butylene Glycol Polysorbate 20 Hydroxyacetophenone 1,2-hexanediol Alcohol Artemisia Argyi Leaf Aqua Phenoxyethanol Chamomile Aloe Vera Leaf Borneol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-27

Description

SODIUM BICARBONATE 0.7%

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

SODIUM BICARBONATE 0.7%

Use

temporarily protects skin 8 helps relieve minor

irritation 8 itching caused by insect bites

Stop Use

If irritation or redness develops or lasts.



Warnings

For external use only.

Ask Doctor

If there is any discomfort during use, please stop using immediately.

Directions

Apply to hands or skin. No rinising required. Discard after use.

Do Not Use

●In children less than 2 months of age or on open skin wounds

When Using

Avoid contact with eyes

If contact occurs,rinse thoroughly with water

Active Ingredient

SODIUM BICARBONATE 0.7%

Other Information

Inactive Ingredients

Water, Butylene Glycol, Polysorbate 20, Hydroxyacetophenone, 1,2-Hexanediol, Alcohol,

Phenoxyethanol, Borneol, Chamomilla Recutita (Matricaria) Flower Extract,

Artemisia Argyi Leaf Extract, Aloe Vera Extract, Mentha Arvensis Extract .

Principal Display Panel

Keep Oot of Reach of Children

In case of accidental ingestion, get medical help or contact a poison control center immediately.




Structured Label Content

Use

temporarily protects skin 8 helps relieve minor

irritation 8 itching caused by insect bites

Purpose

Skin protectant

Stop Use

If irritation or redness develops or lasts.



Warnings

For external use only.

Ask Doctor

If there is any discomfort during use, please stop using immediately.

Directions

Apply to hands or skin. No rinising required. Discard after use.

Do Not Use (Do not use)

●In children less than 2 months of age or on open skin wounds

When Using

Avoid contact with eyes

If contact occurs,rinse thoroughly with water

Active Ingredient

SODIUM BICARBONATE 0.7%

Other Information (Other information)

Inactive Ingredients (Inactive ingredients)

Water, Butylene Glycol, Polysorbate 20, Hydroxyacetophenone, 1,2-Hexanediol, Alcohol,

Phenoxyethanol, Borneol, Chamomilla Recutita (Matricaria) Flower Extract,

Artemisia Argyi Leaf Extract, Aloe Vera Extract, Mentha Arvensis Extract .

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

In case of accidental ingestion, get medical help or contact a poison control center immediately.




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)