PURIFIED WATER- hyaluronic acid injection, solution 
2359 US INC

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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83490-315 LACTOMEDI Vaginal Irrigation

Active Ingredients

purified water

Purposes

Purified Water------------Vaginal Irrigation

Uses

Vaginal douche for disinfection. pH balance, and skin barrier. Relieves minor vaginal like itching or soreness.

Warnings

Do not use the product to areas with scars, eczema, or dermatitis.

Warnings

If swallowed, get medical help or contact a Poison Control Center immediately.

Warnings

Stop use and ask a doctor if

irritation, rash, red spot on the skin, or swelling occurs. These may be signs of a severe condition.

Warnings

When using this product skin irritation and dryness is more likely to occur if you use
another topical acne medication at the same time. If irritation occurs, only use one
topical acne medication at a time.

Warnings

This product is for external use only. Women during menstruation and pregnancy should not use it. Not suitable for children under 3 years of age.

Directions

Use the product as a douche as needed.

Inactive Ingredients

HYALURONIC ACID

Label

LACTOMEDI Vaginal Irrigation

PURIFIED WATER 
hyaluronic acid injection, solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83490-315
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER99.99 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYALURONIC ACID (UNII: S270N0TRQY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83490-315-0150 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product06/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2023
Labeler - 2359 US INC (118974080)
Registrant - 2359 US INC (118974080)
Establishment
NameAddressID/FEIBusiness Operations
isamogu Inc.695695834manufacture(83490-315)

Revised: 6/2023
Document Id: fd0e0a18-24f9-863e-e053-6294a90ac1d5
Set id: fd0b0661-49bc-7152-e053-6394a90a95a7
Version: 2
Effective Time: 20230601
 
2359 US INC