FDA.reportPublic FDA data

insect sting relief lotion

Manufacturer
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Effective date
2024-08-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:17:22

Label at a glance#

ProductInsect sting relief latex 01
Active ingredientSODIUM BICARBONATE
Label structure9 sections

Indications and uses

temporary protects and helps relieve minor skin irritation and itching due to: poison ivy, oak, or sumac insect bites

Dosage and administration

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℉)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Fact

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium bicarbonate (Baking Soda) 5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

temporary protects and helps relieve minor skin irritation and itching due to:

  • poison ivy, oak, or sumac
  • insect bites

Warnings

WARNINGS SECTION

  • For external use only.

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you are

using any other hydrocortisone product

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • side effects occur. You may report side effects to FDA at
  • 1-800-FDA-1088.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 SECTION

Other information

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82953-02082953-020

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BICARBONATE ION Pharmacologic Class Indexing1Indexing - Pharmacologic Class20220121

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-020-01Insect sting relief latex010.9 g in 1 POUCHLOTION0.92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-020INSECT STING RELIEF LATEX 01 (SODIUM BICARBONATE) LOTION [COSMUSES COSMETICS (NINGBO) CO., LTD.]2Current NDC, 1 package rows20240820_1b9e2d4c-bc0c-6ed0-e063-6294a90a9103.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82953-02082953-020-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PROPYLPARABENZ8IX2SC1OHIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BICARBONATE8MDF5V39QOACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
CETETH-255KLY4IOG20IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Insect sting relief latex 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b9e2d4c-bc0c-6ed0-e063-6294a90a91032024-08-19WarningsExact identifier
ndc (package): 82953-020-01
ndc (product): 82953-020
ndc11 (package): 82953002001
spl id: 2005cb8c-ab0b-9d4e-e063-6294a90a861b
spl set id: 1b9e2d4c-bc0c-6ed0-e063-6294a90a9103

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.