Avva Vaginal Douche Gel

Avva Vaginal Douche Gel
SPL v5
SPL
SPL Set ID 9a46a21f-3e62-4e90-84a2-00e99f3d9e9c
Route
VAGINAL
Published
Effective Date 2011-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 mL)
Inactive Ingredients
Carbomer 934 Glycerin Hypromelloses Methylparaben Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-05-20

Description

Active ingredients                             Purpose Benzalkonium Chloride  0.1%          Antimicrobial


Medication Information

Warnings and Precautions


If swallowed, get medical help or contact a poison control center right away.



External use only



Do not use in eyes.

Indications and Usage

Stop use and ask doctor if: Rash or irritation and redness develops.

Discontinue use if any burning, itching, or irritation of the vagina occurs during use. Wash and douche with water. 



Do not douche to prevent pregnancy



During pregnancy



If you have symptoms of pelvic inflammatory disease (PID) or sexually transmitted disease (STD)



To self treat or prevent a STD or PID



After exposure to STD stop using this product and consult a doctor if douching results in pain, soreness, swelling, redness, itching excessive dryness or irritation, or symptoms continue after 7 days. These may indicate a serious condition.

Dosage and Administration

Directions

Insert the gel into the vagina when cleansing is desired, one unit (5.5 ml) each time.

Please read the following instructions carefully before use.

1. Take off any plastic around the tube.

2. Remove the small plastic tip from the top of the applicator.

3. Gently insert the small end of the applicator deep into the vagina. While in this position, squeeze the contents of the applicator to release the gel. Remove the applicator and discard it in a waste container.

Do not use this product if the package seal is broken

Children under 12 years of age: ask doctor.

Description

Active ingredients                             Purpose Benzalkonium Chloride  0.1%          Antimicrobial

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive Ingredients

Carbomer, Glycerin, Hydroxypropylmethylcellulose, Methylparaben, sodium hydroxide, water





Section 51945-4


Avva

Vaginal Douche Gel with Benzalkonium Chloride



0.18 fl oz  5.5 ml







Section 55105-1


Uses: for vaginal cleansing. Kills germs.



Section 55106-9

Active ingredients                             Purpose

Benzalkonium Chloride  0.1%          Antimicrobial


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask doctor if: Rash or irritation and redness develops.

Discontinue use if any burning, itching, or irritation of the vagina occurs during use. Wash and douche with water. 



Do not douche to prevent pregnancy



During pregnancy



If you have symptoms of pelvic inflammatory disease (PID) or sexually transmitted disease (STD)



To self treat or prevent a STD or PID



After exposure to STD stop using this product and consult a doctor if douching results in pain, soreness, swelling, redness, itching excessive dryness or irritation, or symptoms continue after 7 days. These may indicate a serious condition.

Dosage and Administration (34068-7)

Directions

Insert the gel into the vagina when cleansing is desired, one unit (5.5 ml) each time.

Please read the following instructions carefully before use.

1. Take off any plastic around the tube.

2. Remove the small plastic tip from the top of the applicator.

3. Gently insert the small end of the applicator deep into the vagina. While in this position, squeeze the contents of the applicator to release the gel. Remove the applicator and discard it in a waste container.

Do not use this product if the package seal is broken

Children under 12 years of age: ask doctor.

Warnings and Precautions (34071-1)


If swallowed, get medical help or contact a poison control center right away.



External use only



Do not use in eyes.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive Ingredients

Carbomer, Glycerin, Hydroxypropylmethylcellulose, Methylparaben, sodium hydroxide, water





Section 51945-4 (51945-4)


Avva

Vaginal Douche Gel with Benzalkonium Chloride



0.18 fl oz  5.5 ml







Section 55105-1 (55105-1)


Uses: for vaginal cleansing. Kills germs.



Section 55106-9 (55106-9)

Active ingredients                             Purpose

Benzalkonium Chloride  0.1%          Antimicrobial


Advanced Ingredient Data


Raw Label Data

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