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DETTOL FIRST AID ANTISEPTIC- chloroxylenol solution

Reckitt Benckiser (UK) Ltd


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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Dettol®
First Aid Antiseptic
Drug Facts

Active Ingredient
Chloroxylenol 4.8% w/v

Purpose
Antiseptic

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

Warnings
For external use only

Do not use
in the eyes
over large areas of the body

Ask a doctor before use if you have


deep wounds or puncture wounds
animal bites
serious burns

Stop use and ask a doctor if


irritation, sensitization, or allergic reaction occurs. These may be signs of a serious
condition.
condition gets worse or lasts more than one week

Keep out of reach of children. If swallowed, get medical help or contact a Poison
Control Center right away. Do not induce vomiting.
Directions
do not use undiluted product
clean the affected area
dilute 1 tablespoonful (15mL) in 10 oz. (300 mL) of water
apply to affected area and cover with gauze or bandage

Other Information
store between 20-25°C (68-77°F)

Inactive Ingredients
caramel, castor oil soap, isopropyl alcohol (12%), pine oil, water

Questions?
(800) 444-7599 or visit http://www.dettol.co.uk
Manufactured in Britain by:
Reckitt Benckiser Healthcare (UK) Ltd.
Hull, England HU8 7DS

PRINCIPAL DISPLAY PANEL - 500ml Bottle Label


By Appointment to Her Majesty Queen Elizabeth II
Manufacturers of Antiseptics, Air Fresheners,
Polishes, Cleaners and Laundry Products
Reckitt Benckiser plc, Slough
Dettol®
Liquid
FIRST AID ANTISEPTIC
16.90 FL.OZ.
(500ml)
Manufactured in Britain by:
Reckitt Benckiser Healthcare (UK) Ltd.
Hull, England HU8 7DS
#0031023
DETTOL FIRST AID ANTISEPTIC
chloroxylenol solution

Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52031-0875

Route of Administration TOPICAL

Active Ingredient/Active Moiety


Ingredient Name Basis of Strength Strength
Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q) Chloroxylenol 4.8 g in 100 mL

Inactive Ingredients
Ingredient Name Strength
caramel (UNII: T9D99G2B1R)
isopropyl alcohol (UNII: ND2M416302)
white pine oil (UNII: HA5CX6676U)
water (UNII: 059QF0KO0R)

Packaging
Marketing Start Marketing End
# Item Code Package Description
Date Date
NDC:52031- 125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a
1 02/08/1989 05/11/2023
0875-1 Combination Product
NDC:52031- 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a
2 02/08/1989 05/11/2023
0875-2 Combination Product
NDC:52031- 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a
3 02/08/1989 05/11/2023
0875-3 Combination Product
NDC:52031- 750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a
4 02/08/1989 05/11/2023
0875-4 Combination Product
NDC:52031- 2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a
5 02/08/1989 05/11/2023
0875-5 Combination Product

Marketing Information
Application Number or Monograph Marketing Start Marketing End
Marketing Category
Citation Date Date
OTC MONOGRAPH NOT
part333E 02/08/1989 05/11/2023
FINAL

Labeler - Reckitt Benckiser (UK) Ltd (227363660)

Revised: 11/2021 Reckitt Benckiser (UK) Ltd

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