INSECT STING RELIEF LATEX 01- sodium bicarbonate lotion

Insect sting relief latex by

Drug Labeling and Warnings

Insect sting relief latex by is a Otc medication manufactured, distributed, or labeled by Cosmuses Cosmetics (Ningbo) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

STORAGE AND HANDLING

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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
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)

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

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

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Cosmuses Cosmetics (Ningbo) Co., Ltd.		725290934	manufacture(82953-020)