MIRAKEL- benzocine 10%, resorcinol 1.5% cream

mirakel by

Drug Labeling and Warnings

mirakel by is a Otc medication manufactured, distributed, or labeled by Sanvio, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active ingredients Purpose
Benzocaine 10% .........................................................External Analgesic
Resorcinol 1.50%........................................................External Analgesic

Uses

Uses temporary relief of pain, itching and discomfort associated with:

■ rashes
■ minor cuts

■ minor burns
■ minor skin irritations

■ insect bites

Warnings

Warnings
For external use only
When using this product ■ avoid contact with eyes ■ do not apply
over large areas of the body

Stop use and ask a doctor if ■ condition worsens or symptoms persist
for more than 7 days, or clear up and occur again within a few days

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

Keep Out Of Reach of Children

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

Directions

Directions
■ adults and children 12 years and older: apply small amount to
affected area not more than 3-4 times a day.
■ children under 12 years of age: consult a doctor

Other Information

Other Information ■ store at 20-25°C (68-77°F)
■ skin is more sensitive to sunlight when using this product.
■ keep tightly closed after use.

Inactive Ingredients

Inactive ingredients aloe barbadensis (aloe vera) leaf extract,
butylated hydroxytoluene, carbomer, cetyl
alcohol, cholecalciferol, edetate disodium,
glyceryl monostearate, isopropyl palmitate,
maltodextrin, mentha piperita (peppermint) oil,
methylparaben, mineral oil, PEG-40 hydrogenated
castor oil, PEG-100 stearate,petrolatum,
propylene glycol, propyl-paraben, purified
water, retinyl palmitate, sodium lauryl sulfate,
thymus vulgaris (thyme) flower leaf oil, tocopheryl
acetate triethanolamine, xanthan gum.

Questions

Questions? Call 1-888-855-5681

Purpose

Active ingredients Purpose
Benzocaine 10% .........................................................External Analgesic
Resorcinol 1.50%........................................................External Analgesic

Pricipal Display Panel

INGREDIENTS AND APPEARANCE

MIRAKEL 
benzocine 10%, resorcinol 1.5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78589-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	0.1 g  in 1 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)	0.03 g  in 1 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78589-100-01	1 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2020
2	NDC: 78589-100-02	1 g in 1 BOX; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/01/2020

Labeler - Sanvio, Inc. (100812165)

Registrant - Sanvio, Inc. (100812165)

Establishment
Name	Address	ID/FEI	Business Operations
Sanvio, Inc.		100812165	manufacture(78589-100)