WATER-BASED PERSONAL LUBRICANT, AMBOLOVE 001- personal lubricant oil
Shenzhenshi Anbole Technology 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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Water-based Personal Lubricant, AMBOLOVE 001 (240mL)

Active ingredient

butylene glycol (20%): 48g/package or 48mL/package

Inactive ingredient

Inactive ingredient:

water (77.52%): 186.048mL/package

hydroxyethylcellulose (1.6%): 3.84mL/package

polyethylene glycol 300000 (0.5%): 1.2mL/package

phenoxyethanol (0.3%): 0.72mL/package

chlorphenesin (0.08%): 0.192mL/package

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

AMBOLOVE 001 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 240mL 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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Container Label_Ambolove

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Package Label

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Package Label_Ambolove

WATER-BASED PERSONAL LUBRICANT, AMBOLOVE 001
personal lubricant oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72281-3116(NDC:71847-2215)
Route of Administration	CUTANEOUS, EXTRACORPOREAL, VAGINAL, TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUTYLENE GLYCOL (UNII: 3XUS85K0RA) (BUTYLENE GLYCOL - UNII:3XUS85K0RA)	BUTYLENE GLYCOL	48 g in 240 mL

Ingredient Name	Strength
Inactive Ingredients
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) (UNII: 12VCE9HR9E)	3.84 mL in 240 mL
WATER (UNII: 059QF0KO0R)	186.048 mL in 240 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.72 mL in 240 mL
POLYETHYLENE GLYCOL 300000 (UNII: 4QIB4U4CQR)	1.2 mL in 240 mL
CHLORPHENESIN (UNII: I670DAL4SZ)	0.192 mL in 240 mL

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72281-3116-5	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/25/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/25/2018	12/31/2019

Labeler - Shenzhenshi Anbole Technology Ltd (554406461)

Registrant - Shenzhenshi Anbole Technology Ltd (554406461)

Name	Address	ID/FEI	Business Operations
Establishment
Shenzhenshi Anbole Technology Ltd		554406461	label(72281-3116) , relabel(72281-3116)

Revised: 12/2019

Document Id: 9acfdc00-9f30-c724-e053-2995a90af520

Set id: 6aa746a5-95fb-28a7-e053-2991aa0ac5ee

Version: 2

Effective Time: 20191228

Shenzhenshi Anbole Technology Ltd