Label: BOY BUTTER DESENSITIZING LUBRICANT- benzocaine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 24488-043-83 - Packager: Boy Butter Lubes
- 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 September 25, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient:
- Purpose
- Indications:
- Keep out of reach of children
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Warnings:
Premature ejaculation may be due to a condition requiring medical supervision.
- If this product, used as directed, does not provide relief, discontinue use and consult a physician
- Avoid contact with the eye. If you or your partner develop a rash or irritation, such as burning or itching, discontinue use
- If symptoms persist, consult a physician.
- Directions:
- Inactive Ingredients:
- Questions or Comments:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BOY BUTTER DESENSITIZING LUBRICANT
benzocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24488-043 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 71.9395789 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PETROLATUM (UNII: 4T6H12BN9U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) MINERAL OIL (UNII: T5L8T28FGP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYSORBATE 60 (UNII: CAL22UVI4M) GLYCOL DISTEARATE (UNII: 13W7MDN21W) GLYCERIN (UNII: PDC6A3C0OX) COCONUT OIL (UNII: Q9L0O73W7L) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24488-043-83 266 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 09/25/2012 Labeler - Boy Butter Lubes (961956229) Registrant - Creation's Garden Natural Products (961956229) Establishment Name Address ID/FEI Business Operations Creation's Garden Natural Products 961956229 manufacture(24488-043)