SKIN PROTECTANT- sodium bicarbonate liquid

Skin protectant by

Drug Labeling and Warnings

Skin protectant by is a Otc medication manufactured, distributed, or labeled by Shanghai Kejing Cleaning Products Co., Ltd.. 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

-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

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 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 - 86F (15 - 30C)

INACTIVE INGREDIENT

Inactive ingredients   ammonia, cyclohexasiloxane,

cyclopentasiloxane, glycerin, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKIN PROTECTANT 
sodium bicarbonate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 31190-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	5 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 31190-101-01	14 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/18/2016

Labeler - Shanghai Kejing Cleaning Products Co., Ltd. (526877847)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Kejing Cleaning Products Co., Ltd.		526877847	manufacture(31190-101)