Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID afaf9662-3fcb-495b-8692-d0fd77b64f59
Route
TOPICAL
Published
Effective Date 2015-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (5 g)
Inactive Ingredients
Ammonia Glycerin Cyclomethicone 6 Cyclomethicone 5 Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2015-11-10

Description

Active ingredient Sodium Bicarbonate (Baking Soda) 5%


Medication Information

Warnings and Precautions

Warnings

For external use only

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 of 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

Assured's Bug Bite Relief helps to relieve a wide range

of irritation and itching associated with the most common

and annoying insect bites. When you feel the sting, reach

for the soothing relief of Assured's Bug Bite Relief.

Easy. Convenient. Effective.

Always keep it with you. On - the - go or at home.

Section 44425-7

Other information

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

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

  • symptoms last for more than 7 days
  • the condition becomes worse
  • symptoms clear up and then occur again within a few days

Section 50567-7

When using this product

  • avoid contact with eyes

Section 50570-1

Do not use

  • over large areas of the body
  • other than as directed

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 of 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

Description (34089-3)

Assured's Bug Bite Relief helps to relieve a wide range

of irritation and itching associated with the most common

and annoying insect bites. When you feel the sting, reach

for the soothing relief of Assured's Bug Bite Relief.

Easy. Convenient. Effective.

Always keep it with you. On - the - go or at home.

Section 44425-7 (44425-7)

Other information

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

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

  • symptoms last for more than 7 days
  • the condition becomes worse
  • symptoms clear up and then occur again within a few days

Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes

Section 50570-1 (50570-1)

Do not use

  • over large areas of the body
  • other than as directed

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)