insect sting relief lotion

insect sting relief lotion
SPL v2
SPL
SPL Set ID 1b9e2d4c-bc0c-6ed0-e063-6294a90a9103
Route
topical
Published
Effective Date 2024-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
bicarbonate ion (5 g)
Inactive Ingredients
yellow wax glyceryl monostearate propylparaben cetostearyl alcohol edetate disodium glycerin water aloe vera leaf phenoxyethanol methylparaben mineral oil ceteth-25 butylated hydroxytoluene

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-06-14

Purpose

Skin Protectant

Description

Drug Fact


Medication Information

Warnings
  • For external use only.

Uses

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

  • poison ivy, oak, or sumac
  • insect bites

Purpose

Skin Protectant

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

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

Description

Drug Fact

Section 42229-5

Drug Fact

Section 44425-7

Other information

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

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • side effects occur. You may report side effects to FDA at
  • 1-800-FDA-1088.
Section 50569-3

Ask a doctor before use if you are

using any other hydrocortisone product

Section 50570-1

Do not use

  • in or near the eyes
  • for diaper rash; ask a doctor
Section 51945-4

Active Ingredient

Sodium bicarbonate (Baking Soda) 5%


Structured Label Content

Warnings
  • For external use only.

Uses

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

  • poison ivy, oak, or sumac
  • insect bites

Purpose

Skin Protectant

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

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

Section 42229-5 (42229-5)

Drug Fact

Section 44425-7 (44425-7)

Other information

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • side effects occur. You may report side effects to FDA at
  • 1-800-FDA-1088.
Section 50569-3 (50569-3)

Ask a doctor before use if you are

using any other hydrocortisone product

Section 50570-1 (50570-1)

Do not use

  • in or near the eyes
  • for diaper rash; ask a doctor
Section 51945-4 (51945-4)

Active Ingredient

Sodium bicarbonate (Baking Soda) 5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)