ASSURED BUG BITE RELIEF- sodium bicarbonate liquid

Assured by

Drug Labeling and Warnings

Assured by is a Otc medication manufactured, distributed, or labeled by Shanghai Weierya Daily Chemicals Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Sodium Bicarbonate (Baking Soda) 5%

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

Uses   temporary relief of itching and irritation due to

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

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

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

WHEN USING

When using this product

• avoid contact with eyes
  

STOP USE

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
  

KEEP OUT OF REACH OF CHILDREN

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

or contact a Poison Control Center right away.

DOSAGE & 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

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients   ammonia, cyclohexasiloxane,

cyclopentasiloxane, glycerin, water

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASSURED  BUG BITE RELIEF
sodium bicarbonate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58194-029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIA (UNII: 5138Q19F1X)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58194-029-01	14 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/10/2015

Labeler - Shanghai Weierya Daily Chemicals Factory (420359333)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Weierya Daily Chemicals Factory		420359333	manufacture(58194-029)