UTIMI WATER BASED PERSONAL LUBRICANT- personal lubricant lotion 
Shenzhen ZhiHuiChuangXiang Technology 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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Water Based Personal Lubricant, UTIMI, 30mL

Active ingredient

Hydroxyethyl Cellulose

Inactive ingredient

De-lonized Water
Glycerin
Propylene Glycol
Sodium Benzoate
Polysorbate 20
Disodium EDTA
Lactic Acid

Purpose

Utimi Personal Lubricant is a water-based lubricant for penile or vaginal application, intended to moisturize and enhance the ease and comfort of intimate sexual activity as well as supplement for the body's natural lubrication.

This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.

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 container 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 lubricant for penile or vaginal application, intended to moisturize and enhance the ease and comfort of intimate sexual activity as well as supplement for the body's natural lubrication.

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

Dosage & administration

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

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, pleas discontinue to use and consult a physician.

Very slippery surfaces, clean the spills immediately.

This product is not a contraceptive or spermicide.

Keep out of children and pets' reach.

Package label. Principal display panel

As attached.

Container Label_Utimi

UTIMI WATER BASED PERSONAL LUBRICANT 
personal lubricant lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73000-225
Route of AdministrationVAGINAL, RECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5) (HYDROXYETHYL CELLULOSE (140 CPS AT 5%) - UNII:8136Y38GY5) HYDROXYETHYL CELLULOSE (140 CPS AT 5%)0.381 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.027 mL  in 30 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) 0.3 mL  in 30 mL
WATER (UNII: 059QF0KO0R) 25.008 mL  in 30 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.075 mL  in 30 mL
GLYCERIN (UNII: PDC6A3C0OX) 2.538 mL  in 30 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1.665 mL  in 30 mL
LACTIC ACID, DL- (UNII: 3B8D35Y7S4) 0.006 mL  in 30 mL
Product Characteristics
ColorwhiteScoreno score
ShapeFREEFORMSize50mm
FlavorEGG NOGImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73000-225-2030 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/27/2019
Labeler - Shenzhen ZhiHuiChuangXiang Technology Co., Ltd (550748186)
Registrant - Shenzhen ZhiHuiChuangXiang Technology Co., Ltd (550748186)
Establishment
NameAddressID/FEIBusiness Operations
Shenzhen ZhiHuiChuangXiang Technology Co., Ltd550748186manufacture(73000-225) , label(73000-225)

Revised: 3/2019
Document Id: 84d1b350-df53-8c0c-e053-2a91aa0ad73f
Set id: 84d1b350-df6d-8c0c-e053-2a91aa0ad73f
Version: 1
Effective Time: 20190327
 
Shenzhen ZhiHuiChuangXiang Technology Co., Ltd