SPL v3
SPL
SPL Set ID 25a1e070-9228-4ec9-e063-6294a90ad78d
Route
TOPICAL
Published
Effective Date 2024-10-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (5 g)
Inactive Ingredients
Sodium Benzoate Glyceryl Caprylate Phenoxyethanol Picea Abies Leaf Oil Propanediol Xanthan Gum Water Glyceryl Monoundecylenate Honey Polyglyceryl-3 Ricinoleate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-29

Description

Sodium Bicarbonate 5%

Purpose

Skin Protectant


Medication Information

Warnings and Precautions

For external use only.

Purpose

Skin Protectant

Description

Sodium Bicarbonate 5%

Uses

Rapid relief from

  • Deer flies
  • Horse flies
  • Black flies
  • Mosquitoes
  • Bees
  • Wasps
  • Chiggers
  • Other biting & stinging insects

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

  • Insect bites
  • Rashes
  • Eczema
  • Poison ivy/oak/sumac

Section 50565-1

Keep out of reach of children

  • If swallowed, get medical help or contact a Poison control Center right away.
Section 50566-9

Stop use and ask a doctor

  • if condition worsens.
Section 50567-7

When using this product

  • do not get into eyes. If in eyes, rinse thoroughly wiht water.
Section 51727-6

Glycerol Caprylate, Glycerol Undecylenate, Honey Extract, Phenoxyethanol, Picea Abies Extract, Polyglycerol-3 Polyricinoleate, Propanediol, Sodium Benzoate, Water and Xanthan Gum.

Directions

Use cap to puncture seal.

  • Adults and children 2 years and older, apply to affedtec areas as needed.
  • Children under 2 years, ask a doctor.
Package Label

Active Ingredient

Sodium Bicarbonate 5%


Structured Label Content

Uses

Rapid relief from

  • Deer flies
  • Horse flies
  • Black flies
  • Mosquitoes
  • Bees
  • Wasps
  • Chiggers
  • Other biting & stinging insects

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

  • Insect bites
  • Rashes
  • Eczema
  • Poison ivy/oak/sumac

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children

  • If swallowed, get medical help or contact a Poison control Center right away.
Section 50566-9 (50566-9)

Stop use and ask a doctor

  • if condition worsens.
Section 50567-7 (50567-7)

When using this product

  • do not get into eyes. If in eyes, rinse thoroughly wiht water.
Section 51727-6 (51727-6)

Glycerol Caprylate, Glycerol Undecylenate, Honey Extract, Phenoxyethanol, Picea Abies Extract, Polyglycerol-3 Polyricinoleate, Propanediol, Sodium Benzoate, Water and Xanthan Gum.

Purpose

Skin Protectant

Directions

Use cap to puncture seal.

  • Adults and children 2 years and older, apply to affedtec areas as needed.
  • Children under 2 years, ask a doctor.
Package Label

Active Ingredient

Sodium Bicarbonate 5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)