83490-315 LACTOMEDI Vaginal Irrigation

purified water by

Drug Labeling and Warnings

purified water by is a Otc medication manufactured, distributed, or labeled by 2359 US INC, isamogu Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PURIFIED WATER 
hyaluronic acid injection, solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83490-315
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	99.99 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83490-315-01	50 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	06/01/2023	07/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2023	07/29/2024

Labeler - 2359 US INC (118974080)

Registrant - 2359 US INC (118974080)

Establishment
Name	Address	ID/FEI	Business Operations
isamogu Inc.		695695834	manufacture(83490-315)

Revised: 7/2024

Document Id: 1e63a206-a0f2-79e6-e063-6294a90aeab4

34390-5

Set id: fd0b0661-49bc-7152-e053-6394a90a95a7

Version: 3

Effective Time: 20240729