MedPath

AHHH Bite Relief

Approved
Approval ID

25a1e070-9228-4ec9-e063-6294a90ad78d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 27, 2025

Manufacturers
FDA

78271

DUNS: 203447388

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium Bicarbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code78271-041
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium Bicarbonate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (11)

SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
GLYCERYL CAPRYLATEInactive
Code: TM2TZD4G4A
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
SODIUM BICARBONATEActive
Quantity: 5 g in 25 g
Code: 8MDF5V39QO
Classification: ACTIB
PICEA ABIES LEAF OILInactive
Code: 09ATY16WMZ
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERYL MONOUNDECYLENATEInactive
Code: IK8A76Q5G8
Classification: IACT
HONEYInactive
Code: Y9H1V576FH
Classification: IACT
POLYGLYCERYL-3 RICINOLEATEInactive
Code: MZQ63P0N0W
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/29/2024

Package Label

Inner packaging

Outer packaging

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/29/2024

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/29/2024

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/29/2024

Active Ingredient

Sodium Bicarbonate 5%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/29/2024

Purpose

Skin Protectant

WARNINGS SECTION

LOINC: 34071-1Updated: 10/29/2024

For external use only.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 10/29/2024

When using this product

  • do not get into eyes.If in eyes, rinse thoroughly wiht water.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 10/29/2024

Stop use and ask a doctor

  • if condition worsens.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 10/29/2024

Keep out of reach of children

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/29/2024

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.

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AHHH Bite Relief - FDA Drug Approval Details