Drug Fact

Active Ingredient

Sodium bicarbonate (Baking Soda) 5%

Purpose

Skin Protectant

Uses

temporary relief of itching, assicuated with minor skin irritations, inflammation and rashes due to:

eczema, insect bites, poison ivy, oak or sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and more

Warnings

For external use only.

Do not use

in or near the eyes
for diaper rash; ask a doctor

Ask a doctor before use if you are

using any other hydrocortisone product

Stop use and ask a doctor if

condition worsens or if symptoms persist for more than 7 days
symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children if ingested, contact a poison control center right away.

Directions

apply to affected area not more than 3 to 4 times daily
children under 2 years, do not use; ask a doctor

Other information

protect from Excessive Heat: (40℃/104℉)

Inactive Ingredients

Aqua, Paraffinum Liquidum, Glyceryl Stearate, Cetearyl Alcohol, Ceteth-25, Beeswax, Glycerin, Aloe Barbadensis Leaf Extract, Phenoxyethanol, Methylparaben, Propylparaben, Disodium EDTA, BHT.

82953-020

INSECT STING RELIEF LATEX 01
sodium bicarbonate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82953-020
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
CETETH-25 (UNII: 5KLY4IOG20)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82953-020-01	0.9 g in 1 POUCH; Type 1: Convenience Kit of Co-Package	06/14/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	06/14/2024

Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)