After Bite Xtra

After Bite Xtra
SPL v2
SPL
SPL Set ID 22b8b83e-66d6-0caa-e063-6394a90ad6fd
Route
TOPICAL
Published
Effective Date 2025-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.12 g)
Inactive Ingredients
Water Methylparaben Anhydrous Citric Acid Propylparaben Alcohol Glycerin Aloe Vera Leaf .alpha.-tocopherol Acetate Tea Tree Oil Sodium Hydroxide Hypromellose, Unspecified Oat

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Diphenhydramine HCl 2%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Diphenhydramine HCl 2%

Uses

For the temporary relief of pain and itching associated with minor burns minor cuts oscrapes insect bite minor skin irritations rashes due to poison ivy, poison oak, and poison sumac

Dosage

Adults and children over 2 apply to affected are 3 to 4 times day not more

Warnings

For External use only

Directions

Do not use more often than directed

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

Children under 2 years of age : consult a doctor

Do Not Use

on large areas of the body with any other product containing diphenhydramine, even one taken by mouth

Primary Package

Active Ingredients

Diphenhydramine HCl 2%

Secondary Packaging

Inactive Ingredients

Aloe Vera, Ciric Acid, Ethyl Alcohol, Glycerin, Methocel, Methylparaben, Oat beta Glucan, Propylparaben, purified water, sodium hydroxide, tea tree oil, vitamin e

Ask A Doctor Before Use

on chicken pox on measles

When Using This Product

avoid contact with eyes

Stop Use and Ask A Doctor If

conditions worsens if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children

if swollowed, get medical help or contact a poison control center right away.


Structured Label Content

Uses

For the temporary relief of pain and itching associated with minor burns minor cuts oscrapes insect bite minor skin irritations rashes due to poison ivy, poison oak, and poison sumac

Dosage

Adults and children over 2 apply to affected are 3 to 4 times day not more

Purpose

Topical Analgesic

Warnings

For External use only

Directions

Do not use more often than directed

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

Children under 2 years of age : consult a doctor

Do Not Use

on large areas of the body with any other product containing diphenhydramine, even one taken by mouth

Primary Package

Active Ingredients

Diphenhydramine HCl 2%

Secondary Packaging

Inactive Ingredients

Aloe Vera, Ciric Acid, Ethyl Alcohol, Glycerin, Methocel, Methylparaben, Oat beta Glucan, Propylparaben, purified water, sodium hydroxide, tea tree oil, vitamin e

Ask A Doctor Before Use (Ask a doctor before use)

on chicken pox on measles

When Using This Product (When using this product)

avoid contact with eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

conditions worsens if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children (Keep out of reach of children)

if swollowed, get medical help or contact a poison control center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)