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NDC 69524-0555-01 Allegenal-M 7.5 g/100g Details

Allegenal-M 7.5 g/100g

Allegenal-M is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Halal Nutritional Center. The primary component is BENZOCAINE.

Product Information

NDC	69524-0555
Product ID	69524-555_492419ef-c659-3880-e054-00144ff8d46c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Allegenal-M
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZOCAINE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	7.5
Active Ingredient Units	g/100g
Substance Name	BENZOCAINE
Labeler Name	Halal Nutritional Center
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 69524-0555-01 (69524055501)

Pricing Information	N/A
NDC Package Code	69524-555-01
Billing NDC	69524055501
Package	56.7 g in 1 JAR (69524-555-01)
Marketing Start Date	2017-02-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6c5854bb-b51a-4583-9148-6f76c59ff24c Details

Active Ingredient

Benzocaine - USP 7.50% ....

Purpose

Male Genital Desensitizer

Uses:

Helps in the prevention of premature ejaculation.

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 doctor.
If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.

Keep out of reach of children.

Avoid contact with eyes.

Directions:

Apply a small amount to head and shaft of penis before intercourse. Wash product off after intercourse.

Other Ingredients:

Acrylates Copolymer, Allantoin, Aloe Barbadensis Leaf Juice, Aqua (Deionized Water), C13-14 Isoparaffin, Dehydroepiandrosterone (Dhea), Diazolidinyl Urea, Dimethicone, Isopropyl Myristate, Laureth-7, Methyl Paraben, Panax Ginseng Root Extract, Peg-8, Polyacrylamide, Propylene Glycol, Propyl Paraben, Triethanolamine.

SPL UNCLASSIFIED SECTION

Manufactured for Hala Nutritional Center (HNC),

1707 1/2 post Oak Blvd., # 260, Houston, TX 77056,

Toll free: (888) 672-1075, Tel:+1-713-626-7177

website:www.myhalacenter.com

Package Label

HNC

Allegenal M

Prevention of Premature Ejaculation

Nt. wt. 2oz

INGREDIENTS AND APPEARANCE

ALLEGENAL-M

benzocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69524-555
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	7.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
7-KETO-DEHYDROEPIANDROSTERONE (UNII: 2334LJD2E9)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAURETH-7 (UNII: Z95S6G8201)
METHYLPARABEN (UNII: A2I8C7HI9T)
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69524-555-01	56.7 g in 1 JAR; Type 0: Not a Combination Product	02/22/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part348	01/28/2015

Labeler - Halal Nutritional Center (078408264)

Revised: 2/2017

Document Id: 492419ef-c659-3880-e054-00144ff8d46c

Set id: 6c5854bb-b51a-4583-9148-6f76c59ff24c

Version: 3

Effective Time: 20170222