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NDC 63102-0107-01 ACTISEP 2; .1; .5 g/100mL; g/100mL; g/100mL Details
ACTISEP 2; .1; .5 g/100mL; g/100mL; g/100mL
ACTISEP is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Actipharma, Inc. The primary component is BENZOCAINE; CETYLPYRIDINIUM CHLORIDE; MENTHOL, UNSPECIFIED FORM.
Product Information
NDC | 63102-0107 |
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Product ID | 63102-107_c3b0081c-16a9-48ab-b91f-d1d1eb8d6f5d |
Associated GPIs | 88359903242020 |
GCN Sequence Number | 070895 |
GCN Sequence Number Description | benzocaine/menth/cetylpyrd Cl SPRAY 2-0.5-0.1% MUCOUS MEM |
HIC3 | H0A |
HIC3 Description | LOCAL ANESTHETICS |
GCN | 34559 |
HICL Sequence Number | 011964 |
HICL Sequence Number Description | BENZOCAINE/MENTHOL/CETYLPYRIDINIUM CHLORIDE |
Brand/Generic | Generic |
Proprietary Name | ACTISEP |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE |
Product Type | HUMAN OTC DRUG |
Dosage Form | SPRAY |
Route | TOPICAL |
Active Ingredient Strength | 2; .1; .5 |
Active Ingredient Units | g/100mL; g/100mL; g/100mL |
Substance Name | BENZOCAINE; CETYLPYRIDINIUM CHLORIDE; MENTHOL, UNSPECIFIED FORM |
Labeler Name | Actipharma, Inc |
Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part356 |
Listing Certified Through | 2024-12-31 |
Package
Package Images
![Package Image](https://hellopharmacist.nyc3.digitaloceanspaces.com/spl/20181213_d76c26fe-f970-4f4c-8e4a-4db8db3debb0/label.jpg)
NDC 63102-0107-01 (63102010701)
NDC Package Code | 63102-107-01 |
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Billing NDC | 63102010701 |
Package | 30 mL in 1 BOTTLE, SPRAY (63102-107-01) |
Marketing Start Date | 2015-12-28 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d76c26fe-f970-4f4c-8e4a-4db8db3debb0 Details
Active ingredients
Uses:
Warnings:
Methemoglobinemia warning:Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energyDo not exceed recommended dosage.
Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics.If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persist or worsens, see your dentist or doctor promptly.
Do not exceed recommended dosage.
Do not use
- in or near eyes
- for teething
- in children under 2 years of age
If pregnant or breast feeding, ask a health professional before use.
In the event of accidental contact with eyes, flush immediately with water and continuously for 10 minutes. Seek immediate medical attention if pain persists.
Directions:
adults and Children 2 years of age or older: |
spray Actisep several times to affected area in mouth or lips. Do not use more than 4 times a day. |
children between 2 and 12 years of age | should be supervised in the use of this product. |
children under 2 years of age: | do not use |
As a gargle or mouthwash, Adults and Children 12 years and over, place ½ teaspoon (2.5 mL) in ½ glass of warm water several times a day. Do not use more than 4 times a day.
Inactive ingredients:
Other information:
SPL UNCLASSIFIED SECTION
Contains the same active ingredients as Orasep® Spray*
ANTISEPTIC • ANESTHETIC
Alcohol Free
Manufactured in the USA for ActiPharma, Inc.
Dorado, PR 00646
*Orasep® Spray is a registered trademark of Llorens Pharmaceutical Corp.
This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.
INGREDIENTS AND APPEARANCE
ACTISEP
benzocaine, menthol, cetylpyridinium chloride spray |
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Labeler - Actipharma, Inc (079340948) |