Label: NEW LIFE 3% HYDROGEN PEROXIDE FIRST AID ANTISEPTIC- hydrogen peroxide solution
- NDC Code(s): 49681-016-04, 49681-016-16, 49681-016-32
- Packager: New Life Products, Inc.
- Category: HUMAN OTC DRUG LABEL
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 February 2, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Uses
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Warnings
• For external use only. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Do not use: In the eyes or apply over large areas of the body • Longer than one week
Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.
Stop use and ask a doctor if swelling, rash, or fever develops • the condition persists or gets worse • sore mouth symptoms do not improve in 7 days • irritation, pain, redness persists or worsens
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Directions
• For use as a first aid antiseptic:
• clean affected area • apply small amount of product on affected area 1 to 3 times a day • if bandaged, let dry first • may be covered with a sterile bandage
For use as an oral debriding agent (oral rinse):
• adults and children 2 years of age and over:
• mix with an equal amount of water
• swish around in the mouth over the affected area for at least 1 minute and then spit out. Do not swallow.
• use up to 4 times 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 doctor or dentist.
- Other Information
- Inactive Ingredients:
-
SPL UNCLASSIFIED SECTION
Topical Solution USP
FIRST AID ANTISEPTIC
+ Treats minor cuts and abrasions
+ Oral debriding agent
+ Use as a gargle or rinse
DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
New Life Products Inc. • Chicago, IL 60629
Watford WD24 7GN, UK • 800-262-2326
www.newlifesanitizer.comISO 9001, 22716 and cGMP compliant
MADE IN USA
- Packaging
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INGREDIENTS AND APPEARANCE
NEW LIFE 3% HYDROGEN PEROXIDE FIRST AID ANTISEPTIC
hydrogen peroxide solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49681-016 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 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49681-016-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/05/2021 2 NDC:49681-016-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/05/2021 3 NDC:49681-016-32 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/05/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/05/2021 Labeler - New Life Products, Inc. (117815140) Establishment Name Address ID/FEI Business Operations New Life Products, Inc. 117815140 manufacture(49681-016)
