MIRAKEL- benzocine 10%, resorcinol 1.5% cream 
Sanvio, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sanvio Mirakel Cream

Active Ingredients

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

Active Ingredients

Uses

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

■ rashes
■ minor cuts

■ minor burns
■ minor skin irritations

■ insect bites

Uses

Warnings

Warning

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

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

Directions

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

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

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

Questions? Call 1-888-855-5681

Purpose

Purpose


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

Pricipal Display Panel

Label Main Complete

MIRAKEL 
benzocine 10%, resorcinol 1.5% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78589-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.1 g  in 1 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN) 0.03 g  in 1 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78589-100-011 g in 1 TUBE; Type 0: Not a Combination Product06/01/2020
2NDC:78589-100-021 g in 1 BOX; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2020
Labeler - Sanvio, Inc. (100812165)
Registrant - Sanvio, Inc. (100812165)
Establishment
NameAddressID/FEIBusiness Operations
Sanvio, Inc.100812165manufacture(78589-100)

Revised: 7/2020
Document Id: aa7e0774-7f59-5c44-e053-2995a90aa8fe
Set id: a3f56fca-341a-57c6-e053-2a95a90a78bd
Version: 2
Effective Time: 20200715
 
Sanvio, Inc.