CALENDULA OFF- calendula off gel 
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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ACTIVE INGREDIENT

CALENDULA OFF GEL TINC HPUS

USES

Minor cuts, scrapes, burns, skin irritation and diaper rash

INDICATIONS

Condition listed above or as directed by the physician

DOSAGE & ADMINISTRATION SECTION

Apply a thin layer of Gel to the affected area, repeat 3 times a day or as needed.

WARNINGS

This product is to be used for self-limiting conditions

If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product

Keep this and all medication out of reach of children

Do not use if capseal is broken or missing.
Close the cap tightly after use.

INACTIVE INGREDIENTS

ALOE VERA GEL

STORAGE

Store in a cool dark place

QUESTIONS OR COMMENTS

www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com

Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758

image description

CALENDULA OFF 
calendula off gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15631-2310
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15631-2310-01 in 1 CONTAINER03/30/2016
150 g in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:15631-2310-11 in 1 CONTAINER03/30/2016
2100 g in 1 CONTAINER; Type 0: Not a Combination Product
3NDC:15631-2310-21 in 1 CONTAINER03/30/2016
3200 g in 1 CONTAINER; Type 0: Not a Combination Product
4NDC:15631-2310-31 in 1 CONTAINER03/30/2016
4500 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/30/2016
Labeler - Rxhomeo Private Limited d.b.a. Rxhomeo, Inc (650833994)
Establishment
NameAddressID/FEIBusiness Operations
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc650833994manufacture(15631-2310) , label(15631-2310)

Revised: 3/2016
Document Id: de14d02e-c722-4a9a-830c-77627de7bc77
Set id: 5d25e29a-2465-40c5-9f48-4fe69dd14c44
Version: 1
Effective Time: 20160330
 
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc