Label: DERMOPLAST KIDS FIRST AID- benzethonium chloride and benzocaine spray
- NDC Code(s): 16864-660-01
- 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.
Drug Label Information
Updated January 30, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
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.
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Directions
- 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
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 57 g Can Label
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INGREDIENTS AND APPEARANCE
DERMOPLAST KIDS FIRST AID
benzethonium chloride and benzocaine sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16864-660 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 150 mg in 1 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) METHYLAL (UNII: 7H1M4G2NUE) ALOE VERA LEAF (UNII: ZY81Z83H0X) DIMETHYL ETHER (UNII: AM13FS69BX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16864-660-01 57 g in 1 CAN; Type 0: Not a Combination Product 03/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/01/2022 Labeler - Advantice Health, LLC. (192527062)