FDA.reportPublic FDA data

Bite & Sting Soother Spray 2 oz

Manufacturer
Rosemont Ventures, Inc. | Monarch PCM, LLC
Effective date
2022-09-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:52:53

Label at a glance#

ProductBite and Sting Soother
Active ingredientOATMEAL
Label structure8 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to insect bites

Dosage and administration

Shake well and apply as needed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1.0%

Purpose

OTC - PURPOSE SECTION

Colloidal Oatmeal 1.0%............Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to insect bites

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product do not get into eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens
  • 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

Shake well and apply as needed

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis (Aloe Vera) Leaf Extract, Aqua (Water), Azadirachta Indica (Neem) Seed Oil, Bisabolol, Butyrospermum Parkii (Shea) Butter†, Calcium Gluconate, Caprylic/Capric Triglyceride, Citric Acid, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Gluconolactone, Glycerin, Glyceryl Stearate SE, Kaolin, Melaleuca Alternifolia (Tea Tree) Leaf Oil†, Potassium Sorbate, Sodium Benzoate, Squalane, Stearyl Alcohol, Xanthan Gum, Zea Mays (Corn) Starch†, Zinc Oxide.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Effective, natural & safe*

ALL TERRAIN

Bite & Sting Soother

Skin Protectant Spray

Soothes & relieves insect bites & stings

Made with 95+% naturally derived ingredients*

2.0 Fl. Oz. (59 mL)

11

22

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82960-12082960-120-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLUCONOLACTONEWQ29KQ9POTIACT
TEA TREE OILVIF565UC2GIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
SQUALANEGW89575KF9IACT
STEARYL ALCOHOL2KR89I4H1YIACT
SHEA BUTTERK49155WL9YIACT
CALCIUM GLUCONATESQE6VB453KIACT
ALOE VERA LEAFZY81Z83H0XIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
KAOLIN24H4NWX5COIACT
GLYCERINPDC6A3C0OXIACT
ALLANTOIN344S277G0ZIACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
OATMEAL8PI54V663YACTIB
STARCH, CORNO8232NY3SJIACT
AZADIRACHTA INDICA SEED OIL4DKJ9B3K2TIACT
ZINC OXIDESOI2LOH54ZIACT
XANTHAN GUMTTV12P4NEEIACT
LEVOMENOL24WE03BX2TIACT

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
0d9a6329-d15f-aaaf-e063-6394a90a5047e8c08a0e-4b7a-6448-e053-2a95a90a02ed2023-12-28WarningsExact identifier
spl set id: e8c08a0e-4b7a-6448-e053-2a95a90a02ed

Reported adverse events (FAERS/openFDA)#

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