FDA.reportPublic FDA data

insect bites relief spray

Manufacturer
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Effective date
2024-09-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:19:59

Label at a glance#

Productinsect bite relief 01
Active ingredientMENTHOL
Label structure13 sections

Indications and uses

Temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to: eczema, psoriasis, insect bites, detergents, jewelry, cosmetics, soaps, seborrheic dermatitis and more.

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

Protect from excessive heat (40 o C/ 104 o F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Insect bite relief spray

Uses

DOSAGE & ADMINISTRATION SECTION

Temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to: eczema, psoriasis, insect bites, detergents, jewelry, cosmetics, soaps, seborrheic dermatitis and more.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING 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

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or 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.

Other information

STORAGE AND HANDLING SECTION

Protect from excessive heat (40 oC/ 104 oF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Aqua, Menthyl Lactate, Borneol, Butylene Glycol, Glycerin

INDICATIONS & USAGE SECTION

Do not begin use of any hydrocortisone product unless you've asked a doctor. Do not use in the genital area if you have a vaginal discharge. Consult a doctor. Do not use more than directed unless told to do so by a doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82953-01182953-011

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1371206menthol 1 % Topical SprayPSN2
1371206menthol 10 MG/ML Topical SpraySCD2
1371206menthol 1 % Topical SpraySY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-011-01insect bite relief0110 mL in 1 BOTTLE, PLASTICSPRAY102
82953-011-02insect bite relief0120 mL in 1 BOTTLE, PLASTICSPRAY202
82953-011-03insect bite relief0130 mL in 1 BOTTLE, PLASTICSPRAY302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-011INSECT BITE RELIEF 01 (MENTHOL) SPRAY [COSMUSES COSMETICS (NINGBO) CO., LTD.]2Current NDC, 3 package rows20240924_006e457d-bfcd-791a-e063-6294a90a8d66.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82953-01182953-011-03, 82953-011-02, 82953-011-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
BORNEOLM89NIB437XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERINPDC6A3C0OXIACT

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 bite relief 01MENTHOLCosmuses Cosmetics (Ningbo) Co., Ltd.006e457d-bfcd-791a-e063-6294a90a8d662024-09-23WarningsExact identifier
ndc (package): 82953-011-03
ndc (package): 82953-011-02
ndc (package): 82953-011-01
ndc (product): 82953-011
ndc11 (package): 82953001101
ndc11 (package): 82953001103
ndc11 (package): 82953001102
spl id: 22c3e5b9-ffcc-9eb3-e063-6394a90a951e
spl set id: 006e457d-bfcd-791a-e063-6294a90a8d66

Reported adverse events (FAERS/openFDA)#

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