MIEL ROSADA- sodium borate, glycerin solution

Miel Rosada by

Drug Labeling and Warnings

Miel Rosada by is a Otc medication manufactured, distributed, or labeled by Dannso Corp./d.b.a. Essential Products, World Perfume, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                      Purpose

SODIUM BORATE .............................. Antifungal

Glycerin ................................................. Moisturizer

PURPOSE

Use

May help aliviate mouth ulcers

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Antifuncgal

For External Use Only

DOSAGE & ADMINISTRATION

Directions

• clean the affected area
• and dry thoroughly. Apply a thin layer 1 to 3 times daily.
• May be covered with a sterile bandage, let dry first.
• Children under 2 years should consult a physician.

WARNINGS

Warnings For external use only

Avoid Contact with eyes.

When using this product

• do not use on irritated skin, in or near eyes or mocous membranes, on wounds or damaged skin, if prone to allergic reaction
• Fatal if swallowed.

Stop use and ask a doctor if condition persists or gets worse

INACTIVE INGREDIENT

Inactive Ingredients Extract of Roses, Honey , FD&C red # 40, Purified Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIEL ROSADA 
sodium borate, glycerin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70242-127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22)	SODIUM BORATE	0.1 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
HONEY (UNII: Y9H1V576FH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70242-127-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/08/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/01/2015

Labeler - Dannso Corp./d.b.a. Essential Products (059741071)

Registrant - Dannso Corp./d.b.a. Essential Products (059741071)

Establishment
Name	Address	ID/FEI	Business Operations
Dannso Corp./d.b.a. Essential Products		059741071	LABEL(70242-127)

Establishment
Name	Address	ID/FEI	Business Operations
World Perfume, Inc		101312044	MANUFACTURE(70242-127)