SKIN PROTECTANT- sodium bicarbonate liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)

Available from:

Shanghai Kejing Cleaning Products Co., Ltd.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Skin Protectant Uses   temporary relief of itching and irritation due to -insect bites and stings   -poison ivy, oak or sumac

Authorization status:

OTC monograph final

Summary of Product characteristics

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%
PURPOS E
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
SKIN PROTECTANT
sodium bicarbonate liquid
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:3119 0 -10 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO) (BICARBONATE ION -
UNII:HN1ZRA3Q20 )
SODIUM BICARBONATE 5 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
AMMO NIA (UNII: 5138 Q19 F1X)
CYCLO METHICO NE 6 (UNII: XHK3U310 BA)
CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)
GLYCERIN (UNII: PDC6 A3C0 OX)
WATER (UNII: 0 59 QF0 KO0 R)
Shanghai Kejing Cleaning Products Co., Ltd.
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:3119 0 -10 1-0 1
14 g in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
MARKETING IN