Cologne Maca Extra Hot Lubricant, PLAY&JOY, PJ-LBS201-35EU (35mL)

Drug Labeling and Warnings

Drug Details [pdf]

PLAY AND JOY COLOGNE MACA EXTRA HOT LUBRICANT PJ-LBS201-35EU- personal lubricant oil 
INNOVEMED BIO-TECH CO., LTD.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Cologne Maca Extra Hot Lubricant, PLAY&JOY, PJ-LBS201-35EU (35mL)

Active ingredient

butylene glycol (20%): 7g/package or 7mL/package

Inactive ingredient

Inactive ingredient:

water (77.52%)

hydroxyethylcellulose (1.6%)

polyethylene glycol 300000 (0.5%)

phenoxyethanol (0.3%)

chlorphenesin (0.08%)

Purpose

It can achieve higher lubricantion, longer lubrication time and less dosage.

This product is not a contraceptive and does not contain a spermicide.

When using

Virginal dryness and/or intimate sexual activity.

This product is not a contraceptive and does not contain a spermicide.

Do not use

Do not use when wound or skin infection.

It should be cautiously used if you are kind of allergic constitution or you have inflammation.
Do not use if quality seal on the opening of the tube is broken or missing.
Do not use if tamper-evident seal is removed or broken.

Stop use

If irritation or discomfort occurs, discontinue the use and consult a physician.
Very slippery on surfaces, clean spills immediately.

Ask doctor

If irritation or discomfort occurs, discontinue the use and consult a physician.

Ask doctor/pharmacist

Ask doctor/pharmacist when you current use other drugs.

Keep out of reach of children

Keep out of reach of children and away from eyes and ears.

Questions

Please contact us when you have any questions.

Pregnancy or breast feeding

Pregnant or breast feeding women shall follow doctor advice.

Indications & usage

This is a water-based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity, help relieve virginal dryness, and supplement to the body's natural lubricant.

Apply a small amount to genital areas. Reapply as needed or desired.

Dosage & administration

One bottle of 35mL in one package.

Dosage forms & strengths

The lubricant is like oil form.

A small amount one time, or reapply as needed or desired.

The active ingredient strength is 20%.

Warnings

If irritation or discomfort occurs, discontinue the use and consult a physician.
Very slippery on surfaces, clean spills immediately.

This product is not a contraceptive and does not contain a spermicide.

Package label. Principal display panel

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Container label

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Package label

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PLAY AND JOY COLOGNE MACA EXTRA HOT LUBRICANT  PJ-LBS201-35EU
personal lubricant oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72623-350
Route of Administration	CUTANEOUS, EXTRACORPOREAL, VAGINAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA) (BUTYLENE GLYCOL - UNII:3XUS85K0RA)	BUTYLENE GLYCOL	7 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) (UNII: 12VCE9HR9E)	0.56 mL  in 35 mL
WATER (UNII: 059QF0KO0R)	27.132 mL  in 35 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.105 mL  in 35 mL
POLYETHYLENE GLYCOL 300000 (UNII: 4QIB4U4CQR)	0.175 mL  in 35 mL
CHLORPHENESIN (UNII: I670DAL4SZ)	0.028 mL  in 35 mL

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72623-350-22	35 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/23/2018	04/24/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/23/2018	04/24/2019

Labeler - INNOVEMED BIO-TECH CO., LTD. (656116338)

Registrant - INNOVEMED BIO-TECH CO., LTD. (656116338)

Establishment
Name	Address	ID/FEI	Business Operations
INNOVEMED BIO-TECH CO., LTD.		656116338	label(72623-350) , manufacture(72623-350)

Revised: 4/2019

Document Id: 87422fd3-b54f-6e0a-e053-2995a90a5a39

34390-5

Set id: 78832d48-c6e8-28ec-e053-2a91aa0a83ee

Version: 2

Effective Time: 20190424

 

INNOVEMED BIO-TECH CO., LTD.