Label: PHARMACYS PRESCRIPTION- hydrogen peroxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 18027-033-10, 18027-033-12, 18027-033-16 - Packager: AMERICAN CONSUMER PRODUCTS LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 30, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- USES
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Warnings
For external use only.
- flammable, keep away from fire and flame
- will produce serious gastric disturbances if ingested
Do not use
- in the eyes or apply over large areas of the body
- longer than one week
- on deep or puncture wounds, animal bites, or on serious burns
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DIRECTIONS
first aid antiseptic:
- clean affected area
- apply small amount of product on affected area 1-3 times a day
- may be covered with a sterile bandage
- if bandage, let dry first
oral debriding agent (oral rinse):
- adults and children 2 years of age or over:
- mix with an equal amount of water
- swish around in the mouth over affected area for atleast 1 minute then spit out
- use up to 4x daily after meals and at bedtime or as directed by a dentist or doctor
- children under 12 years should be supervised in the use of this product
- children under 2 years of age; consult a dentist or doctor
- Other information
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PHARMACYS PRESCRIPTION
hydrogen peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:18027-033 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 3 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 97 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:18027-033-16 473 g in 1 BOTTLE, PLASTIC 2 NDC:18027-033-10 296 g in 1 BOTTLE, SPRAY 3 NDC:18027-033-12 3785 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/01/2014 Labeler - AMERICAN CONSUMER PRODUCTS LLC (858427334) Establishment Name Address ID/FEI Business Operations NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD 530766098 manufacture(18027-033)