Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ebe9bd4e-9fd5-402a-b2ba-55f6083e33bb
Route
TOPICAL
Published
Effective Date 2016-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bicarbonate Ion (5 g)
Inactive Ingredients
Ammonia Cyclomethicone 6 Cyclomethicone 5 Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-01-18

Description

Active ingredient Sodium Bicarbonate (Baking Soda) 5%


Medication Information

Warnings and Precautions

Warnings

For external use only

Do not use

-over large areas of body

-other than as directed

When using this product

-avoid contact with eyes

Stop use and ask a doctor if

-symptoms last for more than 7 days

-the condition becomes worse

-symptoms clear up and then occur again within a few days



Indications and Usage

Uses  temporary relief of itching and irritation due to

-insect bites and stings   -poison ivy, oak or sumac

Dosage and Administration

Directions

adults and children over 2 years of age:

-apply a small amount directly to the bite, sting or affected area and rub gently

-re-apply as needed

children under 2 years of age: ask a doctor before use

Description

Active ingredient Sodium Bicarbonate (Baking Soda) 5%

Section 44425-7

Other information

store at room temperature 59 - 86F (15 - 30C)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients   ammonia, cyclohexasiloxane,

cyclopentasiloxane, glycerin, water

Section 51945-4

Section 55105-1

Purpose

Skin Protectant

Section 55106-9

Active ingredient

Sodium Bicarbonate (Baking Soda) 5%


Structured Label Content

Indications and Usage (34067-9)

Uses  temporary relief of itching and irritation due to

-insect bites and stings   -poison ivy, oak or sumac

Dosage and Administration (34068-7)

Directions

adults and children over 2 years of age:

-apply a small amount directly to the bite, sting or affected area and rub gently

-re-apply as needed

children under 2 years of age: ask a doctor before use

Warnings and Precautions (34071-1)

Warnings

For external use only

Do not use

-over large areas of body

-other than as directed

When using this product

-avoid contact with eyes

Stop use and ask a doctor if

-symptoms last for more than 7 days

-the condition becomes worse

-symptoms clear up and then occur again within a few days



Section 44425-7 (44425-7)

Other information

store at room temperature 59 - 86F (15 - 30C)

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 51727-6 (51727-6)

Inactive ingredients   ammonia, cyclohexasiloxane,

cyclopentasiloxane, glycerin, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Skin Protectant

Section 55106-9 (55106-9)

Active ingredient

Sodium Bicarbonate (Baking Soda) 5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)