Femiclear Vaginal Cream

Femiclear Vaginal Cream
SPL v5
SPL
SPL Set ID 018ed162-4b07-3dd7-e063-6394a90a00a7
Route
TOPICAL
Published
Effective Date 2023-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Melaleuca Cajuputi Whole (0.01 g) Thymol
Inactive Ingredients
Pentylene Glycol Xanthan Gum Hyaluronic Acid (non-animal Stabilized) Cetyl Esters Wax Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-08-07

Description

Melaleuca 6X HPUS ................................................... Anti-yeast agent Olive Extract (Oleuropein) 5X HPUS..... Anti-microbial and healing agent Thymol 6X HPUS .................................................. Anti-bacterial agent


Medication Information

Warnings and Precautions

For vaginal use only.

FemiClear may damage condoms and diaphragms and cause

them to fail.

FemiClear does not prevent sexually transmitted infections (STIs).

Practice safer sex by using a latex or polyurethane condom to

reduce the risk of getting STIs.

FemiClear does not eliminate the risk of infections.

Indications and Usage

This product is intended to help prevent bacterial vaginosis (BV) and

yeast infections, and to moisturize.

Dosage and Administration

Directions

 Adults and children 12 years or over:

 Wash hands before and after use.

 Squeeze desired amount into applicator.

 Insert applicator into vagina and inject cream.

 Clean applicator after use and reuse.

 Children under 12 years: ask a doctor

Description

Melaleuca 6X HPUS ................................................... Anti-yeast agent Olive Extract (Oleuropein) 5X HPUS..... Anti-microbial and healing agent Thymol 6X HPUS .................................................. Anti-bacterial agent

Section 50565-1

Keep out of the reach of children. If swallowed, get medical

help or contact a Poison Control Center right away.

Section 50566-9

 rash or allergic reaction develops

 vaginal symptoms develop  you get a rash or hives, abdominal

pain, fever, chills, nausea or vomiting

Section 50567-7

 can be used in combination with other medications, please consult a

healthcare professional

 do not use tampons, douches, spermicides or other vaginal products.

Condoms and diaphragms may be damaged and fail to prevent

pregnancy or sexually transmitted infections (STIs).

Section 50569-3

 rash or allergic reaction develops

 vaginal symptoms develop  you get a rash or hives, abdominal

pain, fever, chills, nausea or vomiting

Section 50570-1

if you are allergic to any ingredient in this product

Section 51727-6

Water, Oxygenated Olive Oil, essential oil (natural fragrance), Cetearyl

Olivate, Sorbitan Olivate, Xanthan Gum, Cetyl Esters, Phenethyl Alcohol,

Pentylene Glycol, Hyaluronic Acid

Section 51945-4

Section 53413-1

Call 512.401.3572 or visit femiclear.com.

Section 53414-9

ask a healthcare professional before use.

Section 55105-1

This product is intended to help prevent bacterial vaginosis (BV) and

yeast infections, and to moisturize.

Section 55106-9

Melaleuca 6X HPUS ................................................... Anti-yeast agent

Olive Extract (Oleuropein) 5X HPUS..... Anti-microbial and healing agent

Thymol 6X HPUS .................................................. Anti-bacterial agent

Section 60561-8

 do not use if applicator wrapper is torn, open or incompletely sealed

 do not use if seal over tube opening has been punctured

 Store at 68° – 77° F (20° C – 25° C)


Structured Label Content

Indications and Usage (34067-9)

This product is intended to help prevent bacterial vaginosis (BV) and

yeast infections, and to moisturize.

Dosage and Administration (34068-7)

Directions

 Adults and children 12 years or over:

 Wash hands before and after use.

 Squeeze desired amount into applicator.

 Insert applicator into vagina and inject cream.

 Clean applicator after use and reuse.

 Children under 12 years: ask a doctor

Warnings and Precautions (34071-1)

For vaginal use only.

FemiClear may damage condoms and diaphragms and cause

them to fail.

FemiClear does not prevent sexually transmitted infections (STIs).

Practice safer sex by using a latex or polyurethane condom to

reduce the risk of getting STIs.

FemiClear does not eliminate the risk of infections.

Section 50565-1 (50565-1)

Keep out of the reach of children. If swallowed, get medical

help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

 rash or allergic reaction develops

 vaginal symptoms develop  you get a rash or hives, abdominal

pain, fever, chills, nausea or vomiting

Section 50567-7 (50567-7)

 can be used in combination with other medications, please consult a

healthcare professional

 do not use tampons, douches, spermicides or other vaginal products.

Condoms and diaphragms may be damaged and fail to prevent

pregnancy or sexually transmitted infections (STIs).

Section 50569-3 (50569-3)

 rash or allergic reaction develops

 vaginal symptoms develop  you get a rash or hives, abdominal

pain, fever, chills, nausea or vomiting

Section 50570-1 (50570-1)

if you are allergic to any ingredient in this product

Section 51727-6 (51727-6)

Water, Oxygenated Olive Oil, essential oil (natural fragrance), Cetearyl

Olivate, Sorbitan Olivate, Xanthan Gum, Cetyl Esters, Phenethyl Alcohol,

Pentylene Glycol, Hyaluronic Acid

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call 512.401.3572 or visit femiclear.com.

Section 53414-9 (53414-9)

ask a healthcare professional before use.

Section 55105-1 (55105-1)

This product is intended to help prevent bacterial vaginosis (BV) and

yeast infections, and to moisturize.

Section 55106-9 (55106-9)

Melaleuca 6X HPUS ................................................... Anti-yeast agent

Olive Extract (Oleuropein) 5X HPUS..... Anti-microbial and healing agent

Thymol 6X HPUS .................................................. Anti-bacterial agent

Section 60561-8 (60561-8)

 do not use if applicator wrapper is torn, open or incompletely sealed

 do not use if seal over tube opening has been punctured

 Store at 68° – 77° F (20° C – 25° C)


Advanced Ingredient Data


Raw Label Data

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