DISPOSABLE- povidone-iodine 
CVS Pharmacy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CVS Pharmacy, Inc. Disposable Douche Drug Facts

Active ingredient (in each bottle when mixed with packet)

Povidone-iodine 0.3%

Purpose

Antimicrobial

Use

for temporary relief of minor vaginal irritation or itching

Warnings

For vaginal use only

Do not use

if you have an iodine sensitivity
to prevent pregnancy
during pregnancy
if you have symptoms of pelvic inflammatory disease (PID), such as lower abdominal pain, fever, chills, nausea, vomiting, and/or a pus-like yellow cervical discharge; see a doctor right away
if you have symptoms of sexually transmitted diseases (STD), such as vaginal discharge of an unusual amount, color, or odor, painful and/or frequent urination, genital sores or ulcers; see a doctor right away
to self-treat or prevent an STD or PID
after exposure to an STD

Stop use and ask a doctor if

douching results in pain, soreness, swelling, redness, itching, excessive dryness, or irritation
symptoms continue after 7 days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

Preparing the douche:

remove cap, discard
carefully open the medicated packet and pour into the douche bottle. The contents can stain certain materials
screw nozzle onto the bottle
swirl bottle gently to mix

When and how to douche:

use once daily for seven days, even if symptoms disappear sooner
gently insert nozzle into your vagina, no more than 3 inches, and slowly squeeze bottle
do not close the vaginal opening; douching solution should flow freely out of vagina
use while sitting on the toilet, in the tub, or while standing in the shower

Other information

store at 20-25°C (68-77°F)
an association has been reported between douching and pelvic inflammatory disease (PID), ectopic pregnancy, and infertility. It is not currently known whether douching is causally related to these conditions, but women should be aware of this association.
see a doctor right away if you have symptoms of PID or STD
tamper evident: carton and douche concentrate packet sealed for safety. Do not use if printed seal on carton top or bottom flap is broken or missing, or packet is leaking.

Inactive ingredients

dibasic sodium phosphate, glycerin, hydrogen peroxide, nonoxynol-10, phosphoric acid, purified water

Questions or comments?

1-800-367-4477

Package/Label Principal Display Panel

Compare to the Active Ingredient in Summer’s Eve®

Disposable Douche

Medicated

Antimicrobial

Povidone-Iodine

For Relief of Minor Vaginal Irritation & Itching

# {“#” must represent number of bottles in carton}

Disposable Douche Carton Image 1

Disposable Douche Carton Image 1

Disposable Douche Carton Image 2

Disposable Douche Carton Image 1

Disposable Douche Carton Image 2

DISPOSABLE 
povidone-iodine kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-110
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-110-361 in 1 CARTON; Type 0: Not a Combination Product11/24/200908/17/2013
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 PACKET 8 mL
Part 22 BOTTLE 266 mL
Part 1 of 2
MEDICATED POVIDONE-IODINE 
povidone-iodine solution, concentrate
Product Information
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE.3 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/24/200908/17/2013
Part 2 of 2
QUALITY DISPOSABLE DOUCHE 
inactive douche
Product Information
Route of AdministrationVAGINAL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
NONOXYNOL-10 (UNII: K7O76887AP)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1133 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/24/200908/17/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/24/200908/17/2013
Labeler - CVS Pharmacy (062312574)

Revised: 11/2017
 
CVS Pharmacy