WHITE LABS- hydrogen peroxide liquid 
BIOSTECH CO., 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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Drug Facts

Hydrogen Peroxide 2.80%

Oral Debriding

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

Use up to 2 times daily after meals and at bedtime

children under 13 years of age Do not use

For external use only

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

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

image description

WHITE LABS 
hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70812-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrogen Peroxide (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) Hydrogen Peroxide0.42 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70812-001-021 in 1 CARTON04/01/2018
1NDC:70812-001-0115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:70812-001-041 in 1 CARTON04/01/2018
2NDC:70812-001-0320 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/01/2018
Labeler - BIOSTECH CO., LTD. (687294330)
Registrant - BIOSTECH CO., LTD. (687294330)
Establishment
NameAddressID/FEIBusiness Operations
BIOSTECH CO., LTD.687294330manufacture(70812-001)

Revised: 4/2018
Document Id: 838c3b30-37c8-4e66-a48c-28d3d2ea7899
Set id: b8dfa7fa-6601-4eb3-9473-02128e1557c1
Version: 4
Effective Time: 20180401
 
BIOSTECH CO., LTD.