MAE BY DAMIVA- calendula and hamamelis suppository

Mae by Damiva by

Drug Labeling and Warnings

Mae by Damiva by is a Homeopathic medication manufactured, distributed, or labeled by Damiva Inc., Acino Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active ingredients

Calendula HPUS 1X and 

Hamamelis HPUS 6X:

each less than 1% w/w

PURPOSE

Purpose

Vaginal Discomfort

INDICATIONS & USAGE

Uses:  For soothing relief of vaginal discomfort, dryness, itching, odor and pain.  These uses are based solely on usage in homeopathic medicine.  This product has not been evaluated by the Food and Drug Administration for safety or efficacy. 

Warnings

For vaginal use only. 

Do not use if you have an underlying gynecological medical condition or infection e.g. yeast or bacterial infection, sexually transmitted diseases, pelvic inflammatory disease, tenderness, swelling, discharge, chills, nausea, vomiting, rash or increased pain. 

If symptoms persist or worsen, or if new symptoms appear, consult a doctor as these could be signs of a serious condition. 

If you are pregnant or breast-feeding, ask a health professional before use. 

Keep out of reach of children.  

Store at 68-77 °F. 

DOSAGE & ADMINISTRATION

Directions: Remove plastic wrap from ovule.  Using a clean finger, insert one suppository vaginally as far as comfortable.  Use as needed, or every 2 to 3 days, to a maximum of one ovule per day.  May use at bedtime to prevent product leakage.  Best results may occur after consecutive use of 10 ovules. 

INACTIVE INGREDIENT

Inactive ingredients:

Garcinia indica, Invert Sugar, Sucrose, Theobroma cacao (<30% w/w)

PRINCIPAL DISPLAY PANEL

100% natural
vaginal suppository.

Feel like a teenager again,
but with better judgement.

mae
by damiva

Homeopathic formula
10 ovule suppositories 1.9 g each. Net weight 19 g.

INGREDIENTS AND APPEARANCE

MAE BY DAMIVA 
calendula and hamamelis suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69316-321
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 [hp_X]
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) (HAMAMELIS VIRGINIANA LEAF - UNII:T07U1161SV)	HAMAMELIS VIRGINIANA LEAF	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
SUCROSE (UNII: C151H8M554)
COCOA BUTTER (UNII: 512OYT1CRR)

Product Characteristics
Color	white	Score
Shape	OVAL	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69316-321-10	10 in 1 BOX	11/10/2014
1		1 in 1 CELLO PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/10/2014

Labeler - Damiva Inc. (203086327)

Establishment
Name	Address	ID/FEI	Business Operations
Acino Products, LLC		019385518	manufacture(69316-321)