ASSURED BUG BITE RELIEF- sodium bicarbonate liquid 
Huijing (Shanghai) Bio-tech Co., Ltd

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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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

•over large areas of the 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

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

or contact a Poison control Center right away.

Directions

adults and children 2 years of age and over:

•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

Other information

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

Inactive ingredients  ammonia, cyclohexasiloxane,

cyclopentasiloxane, glycerin, water

image description

ASSURED  BUG BITE RELIEF
sodium bicarbonate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71537-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71537-005-0114 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/01/2017
Labeler - Huijing (Shanghai) Bio-tech Co., Ltd (544482337)
Establishment
NameAddressID/FEIBusiness Operations
Huijing (Shanghai) Bio-tech Co., Ltd544482337manufacture(71537-005)

Revised: 12/2017
Document Id: 88460839-2a41-4c5d-8349-3ac83ecde2dd
Set id: ca186e0b-e0bc-494f-b01f-faeabc238dc3
Version: 1
Effective Time: 20171212
 
Huijing (Shanghai) Bio-tech Co., Ltd