WHITE LABS- hydrogen peroxide liquid

White Labs by

Drug Labeling and Warnings

White Labs by is a Otc medication manufactured, distributed, or labeled by BIOSTECH CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Hydrogen Peroxide 2.80%

PURPOSE

Oral Debriding

INDICATIONS & USAGE

Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth

DOSAGE & ADMINISTRATION

Use up to 2 times daily after meals and at bedtime

children under 13 years of age Do not use

WARNINGS

For external use only

ASK DOCTOR

The condition persists or gets worse

Sore mouth symptoms do not improve in 7 days

Irritation, pain or redness persists or worsens

Swelling, rash or fever develops

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

INACTIVE INGREDIENT

Distilated water, Polyvinyl alcohol, Titanium dioxide, Poloxamer 407, Glycerine, PEG400, Ethanol, PVP K29/32(Povidone), PVP K90(Povidone), Aerosil 200, Flavor(Applemint HF62184), Citric Acid, Sodium Citric Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WHITE LABS 
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70812-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrogen Peroxide (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	Hydrogen Peroxide	0.42 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLOXAMER 407 (UNII: TUF2IVW3M2)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
ALCOHOL (UNII: 3K9958V90M)
POVIDONE K29/32 (UNII: 390RMW2PEQ)
POVIDONE K90 (UNII: RDH86HJV5Z)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MENTHA SUAVEOLENS WHOLE (UNII: G0O5N5EA8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70812-001-02	1 in 1 CARTON	04/01/2018
1	NDC: 70812-001-01	15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 70812-001-04	1 in 1 CARTON	04/01/2018
2	NDC: 70812-001-03	20 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	04/01/2018

Labeler - BIOSTECH CO., LTD. (687294330)

Registrant - BIOSTECH CO., LTD. (687294330)

Establishment
Name	Address	ID/FEI	Business Operations
BIOSTECH CO., LTD.		687294330	manufacture(70812-001)