NDC | 60886-101-11 |
Set ID | fd417d43-1f15-4142-a428-952b9ab05411 |
Category | HUMAN OTC DRUG LABEL |
Packager | WTFN INC. DBA CLASSIC EROTICA |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT:
- PURPOSE:
- USES:
-
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
-
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)