ASSURED BUG BITE RELIEF- sodium bicarbonate liquid 
Shanghai Weierya Daily Chemicals Factory

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Sodium Bicarbonate (Baking Soda) 5%

Purpose

Skin Protectant

Uses   temporary relief of itching and irritation due to

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

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

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

or contact a Poison Control Center right away.

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

Other information

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

Inactive ingredients   ammonia, cyclohexasiloxane,

cyclopentasiloxane, glycerin, water

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.

copy of label

ASSURED  BUG BITE RELIEF
sodium bicarbonate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58194-039
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
GLYCERIN (UNII: PDC6A3C0OX)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58194-039-0114 g in 1 APPLICATOR; Type 0: Not a Combination Product11/10/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/10/2015
Labeler - Shanghai Weierya Daily Chemicals Factory (420359333)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai Weierya Daily Chemicals Factory420359333manufacture(58194-039)

Revised: 6/2016
Document Id: 22bc3c5a-e75c-4843-b6a2-7be76272f76c
Set id: fd94539a-0df7-4557-9818-c0f3652574a0
Version: 1
Effective Time: 20160630
 
Shanghai Weierya Daily Chemicals Factory