PREVENTION WOUND AND BURN- hydrogen peroxide, menthol liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
Prevention Health Sciences, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose First aid antiseptic Topical analgesic Uses first aid to help prevent infection in minor cuts, scrapes and burns. Do not use - in or near eyes - over large areas of the body Stop use and ask a doctor if - condition gets worse - symptoms last more than 7 days or clear up and occur again within a few days
Authorization status:
OTC monograph not final
Authorization number:
69951-003-04

PREVENTION WOUND AND BURN- hydrogen peroxide, menthol liquid

Prevention Health Sciences, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Prevention Wound and Burn

Drug Facts

Active ingredient

Hydrogen peroxide 3%

Menthol 0.1%

Purpose

First aid antiseptic

Topical analgesic

Uses first aid to help prevent infection in minor cuts, scrapes and burns.

Warnings

For external use only

Do not use

in or near eyes

over large areas of the body

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

Stop use and ask a doctor if

condition gets worse

symptoms last more than 7 days or clear up and occur again within a few days

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

away.

Directions

Adults and children 2 years of age and older:

clean the affected area

apply to affected area 1 to 3 times daily

may be covered with a sterile bandage

if bandaged, let dry first

Children under 2 years old: ask a doctor

Inactive ingredients citric acid, deionized water, edetate disodium, glycerin, peppermint oil, saccharin

sodium, SD alcohol, sodium citrate,sodium lauryl sulfate, zinc chloride

Questions? (800) 473-1205

Manufactured by:

Manufactured by:

Prevention Health Sciences, Inc.

Raleigh, IL 62977

PREVENTION™ WOUND AND BURN

FIRST AID ANTISEPTIC

with Pain Relief

For Minor Cuts, Scrapes & Burns

USED BY PROFESSIONALS

4 FL OZ - 118 ML

PREVENTION WOUND AND BURN

hydrogen peroxide, menthol liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 9 51-0 0 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO GEN PERO XIDE (UNII: BBX0 6 0 AN9 V) (HYDROGEN PEROXIDE -

UNII:BBX0 6 0 AN9 V)

HYDROGEN

PEROXIDE

3 g in 10 0 mL

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

0 .1 g

in 10 0 mL

Prevention Health Sciences, Inc.

Inactive Ingredients

Ingredient Name

Stre ng th

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

WATER (UNII: 0 59 QF0 KO0 R)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

ZINC CHLO RIDE (UNII: 8 6 Q357L16 B)

GLYCERIN (UNII: PDC6 A3C0 OX)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 9 9 51-0 0 3-

118 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 3/29 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 3/29 /20 19

Labeler -

Prevention Health Sciences, Inc. (968930540)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Preventio n Health Sciences, Inc.

9 6 8 9 30 540

ma nufa c ture (6 9 9 51-0 0 3)

Revised: 3/2019

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