Hug A Booboo Medicated Booboo Wipes Solution
FDA Label NDC 61333-218

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lights Medical Manufacture Co., Ltd. for the product Hug A Booboo Medicated Booboo Wipes (NDC 61333-218). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, indications & usage, warnings, do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzalkonium Chloride 0.1%

Benzocaine 4% 

Purpose

First Aid Antiseptic

Topical Anesthetic

Indications & Usage

Uses:

First aid for temporary relief of pain and itching and to help prevent infection in minor cuts, scrapes, burns

Warnings

For external use only.

Flammable

Do not use near heat, flame, or fire, or while smoking

Allergy Alert

do not use this product if you have a history of allergy to local anesthetics such as procaine, benzocaine, or other "caine" anesthetics

Do Not Use

  • in the eyes
  • over large areas of the body

Otc - Ask Doctor

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Otc - When Using

When using this productavoid contacting with eyes

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens or symptoms persists for more then 7 days
  • symptoms clear up and occur again with a few days

Otc - Keep Out Of Reach Of Children

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

Directions

  • For adults and children 2 yeas of age or older: gently wipe the affacted area 1-3 times daily with a clean cloth
  • Children under 2 yeas of age: consult a doctor

Other Information

Store at room temperature 20-25 C (68-77 F). Avoid direct sunlight

Inactive Ingredient

Poloxamer, PEG-400, Glycerin, NaCl, Water

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