Personal Lubricant, PLAY&JOY, PJ Bullet Capsule (1.2g *10)

Drug Labeling and Warnings

Drug Details [pdf]

PJ BULLET CAPSULED- personal lubricant capsule, gelatin coated 
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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Personal Lubricant, PLAY&JOY, PJ Bullet Capsule (1.2g *10)

Active ingredient

Dimethicone: 0.324g/capsule

Inactive ingredient

Inactive ingredient:

Cyclopentasiloxane: 0.54g/capsule

Dimethiconol: 0.036g/capsule

water: 0.033g/capsule

gelatin: 0.078g/capsule

glycerin: 0.189g/capsule

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 / Anal 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 anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity, help relieve anal / virginal dryness, and supplement to the body's natural lubricant.

Place one capsule into anal / virginal once time.

Dosage & administration

1.2g of one capsule, 10 capsules in one package.

Dosage forms & strengths

The lubricant is like oil form.

One capsule (0.9g lubricant and 0.3g gelatin coated) once time.

The active ingredient strength is 0.324g.

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

PJ BULLET CAPSULED 
personal lubricant capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72623-325
Route of Administration	VAGINAL, RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.324 g  in 1.2 g

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)	0.078 g  in 1.2 g
WATER (UNII: 059QF0KO0R)	0.033 g  in 1.2 g
GLYCERIN (UNII: PDC6A3C0OX)	0.189 g  in 1.2 g
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)	0.54 g  in 1.2 g
DIMETHICONOL GUM (UNII: 4MJ9GU3T1P)	0.036 g  in 1.2 g

Product Characteristics
Color	brown	Score	no score
Shape	BULLET	Size	10mm
Flavor	EGG NOG	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72623-325-11	10 in 1 PACKAGE	02/18/2019	04/24/2019
1	NDC: 72623-325-01	1.2 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/18/2019	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(72623-325) , manufacture(72623-325)

Revised: 4/2019

Document Id: 87422fd3-b560-6e0a-e053-2995a90a5a39

34390-5

Set id: 81e74600-c7bc-c18c-e053-2991aa0a19e7

Version: 2

Effective Time: 20190424