Label: MAX 4 MEN - MAX CONTROL MALE SEX PROLONG UNSCENTED- benzocaine gel
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Contains inactivated NDC Code(s)
NDC Code(s): 60886-101-11 - Packager: WTFN INC. DBA CLASSIC EROTICA
- 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 March 16, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT:
- PURPOSE:
- USES:
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WARNING:
For External Use Only.
Do Not Use:
• on broken or inflamed skin
• if partner is pregnant
• on large areas of the body and/or orallyWhen Using This Product
- Apply to Penile Area Only
- Avoid Contact with Eyes.
- If Irritation Occurs, Discontinue Use
- Do Not Use More Than Directed
Stop use and consult a doctor
• If you or your partner develop a rash or irritation such as burning or itching
• If this product, used as directed, does not provide relief. Premature Ejaculation may be due to a condition requiring medical supervision. - KEEP OUT OF REACH OF CHILDREN
- SPL UNCLASSIFIED SECTION
- DIRECTIONS:
- OTHER INFORMATION:
- INACTIVE INGREDIENTS:
- QUESTIONS OR COMMENTS:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MAX 4 MEN - MAX CONTROL MALE SEX PROLONG UNSCENTED
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60886-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERETH-26 (UNII: NNE56F2N14) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) POLYSORBATE 20 (UNII: 7T1F30V5YH) POLYSORBATE 60 (UNII: CAL22UVI4M) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SQUALANE (UNII: GW89575KF9) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60886-101-11 15 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 03/11/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/11/2018 Labeler - WTFN INC. DBA CLASSIC EROTICA (063659117) Establishment Name Address ID/FEI Business Operations Cosmetic Enterprises Ltd 017701475 manufacture(60886-101)
