CALIFLORA - calendula officinalis flowering top gel 
Nature's Way Products, 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.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active Ingredients (HPUS):  Calendula officinalis

ALCOHOL

CARBOMER HOMOPOLYMER TYPE C

EDETIC ACID

METHYLPARABEN

PROPYLPARABEN

WATER

TROLAMINE

WITCH HAZEL

Boericke and Tafel Brand:

Directions: For adult and children 2 years of age and older: Apply liberally to affected area as often as necessary. Children under 2:  Consult a doctor.

Soothes, cools and temporarily relieves pain, itch, and symptoms of chapping, peeling, or scaling, from sun and windburn and minor burns, cuts, scrapes, abrasions, cracked lips, and skin irritations.

Soothes, cools, relieves sunburn, windburn, burns, cuts, chapped lips, skin irritations.

For external use only.  Avoid contact with eyes. If condition worsens or does not improve within 7 days,  consult a doctor.

Keep out of the reach of children.

In case of accidental ingestion, see professional assistance or contact a Poison Control Center immediately.

Califlora 2.75 oz

Califlora 2.75 oz





CALIFLORA 
calendula officinalis gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-5190
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 78 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
CARBOMER HOMOPOLYMER TYPE C 
EDETIC ACID 
METHYLPARABEN 
PROPYLPARABEN 
WATER 
TROLAMINE 
WITCH HAZEL 
Packaging
#Item CodePackage Description
1NDC:53499-5190-81 in 1 CARTON
178 g in 1 TUBE
2NDC:53499-5190-41 in 1 CARTON
228 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/01/2006
Labeler - Nature's Way Products, Inc. (153970520)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe Mexico SA DE CV824412357manufacture

Revised: 08/2010
Document Id: 366b36b7-60f1-4f7d-9563-8b86b6d6c7d2
Set id: 6b4e85c7-b33e-4331-8981-8679b0518bab
Version: 1
Effective Time: 20100825
 
Nature's Way Products, Inc.