After Bite Xtra

After Bite Xtra
SPL v2
SPL
SPL Set ID af965c5c-072a-569f-e053-2995a90a017e
Route
TOPICAL
Published
Effective Date 2018-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (20 mg)
Inactive Ingredients
Aloe Vera Leaf Anhydrous Citric Acid Alcohol Methylparaben Tea Tree Oil Methylcellulose (100 Cps) Oatmeal Water Sodium Hydroxide .alpha.-tocopherol Acetate Glycerin Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-01

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
  • scrapes
  • insect bites
  • minor skin irritations
  • rashes due to poison ivy, poison oak, and poison sumac
Warnings

For external use only

Directions

Directions

  • do not use more than directed
  • adults and children over 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
Do Not Use

Do not use

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

When using this product avoid contact with eyes.

Package Labeling

Active Ingredient

Diphenhydramine HCl 2%

Inactive Ingredients

Aloe Vera, Citric 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
Stop Use and Ask A Doctor If

Stop use and ask a doctor if

  • condition 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 swallowed, 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
  • scrapes
  • insect bites
  • minor skin irritations
  • rashes due to poison ivy, poison oak, and poison sumac
Purpose

Topical Analgesic

Warnings

For external use only

Directions

Directions

  • do not use more than directed
  • adults and children over 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
Do Not Use (Do not use)

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
When Using (When using)

When using this product avoid contact with eyes.

Package Labeling

Active Ingredient

Diphenhydramine HCl 2%

Inactive Ingredients

Aloe Vera, Citric 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)

Ask a doctor before use

  • on chicken pox
  • on measles
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if

  • condition 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)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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