Label: DERMOPLAST FIRST AID- benzethonium chloride and benzocaine spray
- NDC Code(s): 16864-670-01
- Packager: Advantice Health, 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.
Updated March 12, 2020
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
For external use only
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.
When using this product
- avoid contact with eyes. Do not spray in the face or mouth.
- use only as directed
- intentional misuse by deliberately concentrating or inhaling the contents can be harmful or fatal
- do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
Stop use and ask a doctor if
- condition worsens or symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
- itching, rash or irritation develops
- clean the affected area
Adults and children 2 years of age and older apply a small amount to affected area 1 to 3 times daily Children under 2 years of age consult a doctor
- to use this product, hold the can 6 to 12 inches away from the affected area. Direct spray nozzle towards skin and press button to activate spray.
- to apply to face, spray in palm of hand and gently apply
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 78 g Can Label
INGREDIENTS AND APPEARANCE
DERMOPLAST FIRST AID
benzethonium chloride and benzocaine spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16864-670 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 2 mg in 1 g BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) DIPROPYLENE GLYCOL (UNII: E107L85C40) CYCLOMETHICONE (UNII: NMQ347994Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ISOBUTANE (UNII: BXR49TP611) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16864-670-01 78 g in 1 CAN; Type 0: Not a Combination Product 01/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 01/01/2010 Labeler - Advantice Health, LLC (192527062)