XXL FOR MEN- anemarrhena asphodeloides cream

XXL FOR MEN by

Drug Labeling and Warnings

XXL FOR MEN by is a Homeopathic medication manufactured, distributed, or labeled by HOT PRODUCTIONS AND VERTRIEBS GMBH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Anemarrhena Asphodeloides 0.01x HPUS

PURPOSE

Penis enhancement

USE

AFor temporary penis enhancement

WARNINGS

For external use only.
Avoid contact with the eyes or broken skin.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• Massage the cream into the entire length of the penis. To ensure the XXL Cream can develop its full potential it should be used over a prolonged period of time

INACTIVE INGREDIENTS

Aqua (Water), Hydrogenated Polyisobutene, Glycerin, Cetearyl Olivate, Sorbitan Olivate, Macadamia Ternifolia Seed Oil, Chondrus Crispus (Carrageenan), Xanthan Gum, Anemarrhena Asphodeloides Root Extract, Parfum (Fragrance), Hydrolyzed Soy Protein, Benzyl Alcohol, Benzoic Acid, Glucose, Sorbic Acid, Sodium Hydroxide, Limonene, Linalool, Phenoxyethanol, Alpha-Isomethyl Ionone

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XXL FOR MEN 
anemarrhena asphodeloides cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71326-303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ANEMARRHENA ASPHODELOIDES ROOT (UNII: U0OC9BJL0I) (ANEMARRHENA ASPHODELOIDES ROOT - UNII:U0OC9BJL0I)	ANEMARRHENA ASPHODELOIDES ROOT	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
GLYCERIN (UNII: PDC6A3C0OX)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
MACADAMIA OIL (UNII: 515610SU8C)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
SORBIC ACID (UNII: X045WJ989B)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+)- (UNII: F4VNO44C09)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71326-303-51	1 in 1 BOX	08/30/2018
1	NDC: 71326-303-11	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/30/2018

Labeler - HOT PRODUCTIONS AND VERTRIEBS GMBH (300011984)

Establishment
Name	Address	ID/FEI	Business Operations
System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH		328825757	manufacture(71326-303)