Label: WART REMOVER SET oil
- NDC Code(s): 83436-001-01
- Packager: RD2 GROUP, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 May 4, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
-
Warnings
For external use only. Keep out of reach of children. Avoid contact with
eyes. If product gets into the eye, flush with water for 15 minutes. Avoid
inhaling vapors.
Cap tightly and store at room temperature away from heat
Avoid long-term contact with air while using.
The liquid can get easily volatilized & crystallized, tighten the cap after use. - Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
Directions
soak wart in warm water at 30-35C for 5 minutes, dry area thoroughly, apply
the wart remover essence on the area and keep for 10 minutes, when the
essence is completely absorbed, apply the wart remover, cream and let dry,
repeat this procedure once or twice daily as needed (until wart is removed)
for up to 12 weeks -
Inactive ingredients
Water, Glycerin, Squalane, Caprylic Capric Triglyceride, Propylene Glycol, camellia sinensis leaf extract, Betaine, Cetearyl alcohol, Isononyl isononanoate, CHONDRUS CRISPUS, Hydroxyethyl urea, Polydimethylsiloxane, Trehalose, Erythritol, butyrospermum parkii extract, Isosorbide dimethyl ether, Glyceryl stearate, Tocopherol Acetate, 1,2-Hexanediol, P-hydroxyacetophenone, Cetearyl glucoside, Allantoin, Potassium cetyl phosphate, Carbomer, Hydroxypinacolone retinoate, Triethanolamine, portulaca oleracea l. Extract, Xanthan gum, Laureth-7
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WART REMOVER SET
wart remover set oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83436-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SQUALANE (UNII: GW89575KF9) GREEN TEA LEAF (UNII: W2ZU1RY8B0) BETAINE (UNII: 3SCV180C9W) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) CHONDRUS CRISPUS (UNII: OQS23HUA1X) HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR) DIMETHICONE (UNII: 92RU3N3Y1O) TREHALOSE (UNII: B8WCK70T7I) ERYTHRITOL (UNII: RA96B954X6) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ALLANTOIN (UNII: 344S277G0Z) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) HYDROXYPINACOLONE RETINOATE (UNII: NJ3V2F02E1) XANTHAN GUM (UNII: TTV12P4NEE) LAURETH-7 (UNII: Z95S6G8201) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) TROLAMINE (UNII: 9O3K93S3TK) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83436-001-01 30 mL in 1 BOX; Type 0: Not a Combination Product 05/04/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 05/04/2023 Labeler - RD2 GROUP, LLC (942996682) Establishment Name Address ID/FEI Business Operations RD2 GROUP, LLC 942996682 label(83436-001) , manufacture(83436-001)
