SKIN PROTECTANT - sodium bicarbonate liquid 
Shanghai Kejing Cleaning Products 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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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

-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


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 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 - 86F (15 - 30C)

Inactive ingredients   ammonia, cyclohexasiloxane,

cyclopentasiloxane, glycerin, water

copy of label

SKIN PROTECTANT 
sodium bicarbonate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31190-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE5 g  in 100 g
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:31190-101-0114 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/18/2016
Labeler - Shanghai Kejing Cleaning Products Co., Ltd. (526877847)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai Kejing Cleaning Products Co., Ltd.526877847manufacture(31190-101)

Revised: 1/2016
Document Id: 6a0e462b-dbca-4b9c-b35f-ea3028ebabea
Set id: ebe9bd4e-9fd5-402a-b2ba-55f6083e33bb
Version: 1
Effective Time: 20160118
 
Shanghai Kejing Cleaning Products Co., Ltd.