ZEROMA7- peppermint oil, camphor oil gel 
Ingenue Care 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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Zeroma7

Uses

Uses Aroma therapy blend essential oil for temporary relieves minor aches, pains of muscles and joints associated with:

Arthritis Simple backache Strains Bruises Sprains

Warnings

For external use only

Do not use on wounds or damaged skin with a heating pad

if you are allergic to any ingredients of this product

with other external analgesic products

When using this product

Use only as directed

avoid contact with eyes, mucous membranes or rashes

do not bandage tightly

Stop use and ask a doctor if

rash, itching, or excessive skin irritation develops

conditions worsen

symptoms persist for more than 7 days

symptoms 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 (1-800-222-1222) right away.

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

Active Ingredients

Peppermint Oil 8% ------------------------------------ Topical Analgesic

Camphor Oil 8% --------------------------------------- Topical Analgesic

Purpose

Topical Analgesic

Directions

Adults and children 12 years of age and over:

Clean and dry affected area

Remove patch from film

Apply to affected area no more than 3 to 4 times daily for 7 days

Remove patch from skin after at most 8 hours’ application

Children undress 12 years of age: consult a doctor

Inactive Ingredients

Gaultheria Procumbens (Wintergreen) Oil, Rosmarinus Officinalis (Rosemary) Oil, Citrus Paradisi (Grapefruit) Oil, Heterotheca Inuloides (Arnica Herbal) Oil, Aloe Vera Leaf Extract, Witch Hazel, Olive Oil, Carbomer, Water, Stearic Acid, Propylene Glycol, Isopropyl Palmitate, Cetyl Alcohol, Glycerol Stearate, Lanolin, Polymethoxy Bicyclic Oxazolidine, Mineral Oil & Lanolin Alcohol, Allantoin, Tocopherol Acetate, Aloe Vera Gel, Methyl Paraben, Urea, Potassium Hydroxide, Chloroxylenol, Propyl Paraben, Sodium Hydroxide.

Zeroma7

ZEROMA Label Review by JK 100118

ZEROMA7 
peppermint oil, camphor oil gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72589-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)6.8 g  in 85 g
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL6.8 g  in 85 g
Inactive Ingredients
Ingredient NameStrength
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72589-100-0185 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2018
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/08/2018
Labeler - Ingenue Care Inc (111556736)
Registrant - Ingenue Care Inc (111556736)
Establishment
NameAddressID/FEIBusiness Operations
Ingenue Care Inc111556736manufacture(72589-100)

Revised: 10/2018
Document Id: 77c1c020-9172-6a35-e053-2991aa0a706d
Set id: 77bbd207-4ec2-6fd9-e053-2991aa0a69fd
Version: 2
Effective Time: 20181008
 
Ingenue Care Inc