CALIFLORA- calendula officinalis gel 
Schwabe North America, 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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Califlora

Active ingredient

Contains 10% CALENDULA OFFICINALIS 1X

Inactive Ingredient

CARBOMER 
ETHYL ALCOHOL
PURIFIED WATER
SODIUM HYDROXIDE
WITCH HAZEL DISTILLATE

Dosage & Administration

Apply think layer to affected area. For best results, use promptly after injury or trauma occurs.

For minor burns, first run cool water on the burn area and dry.

For minor skin irritation, first wash the area with mild soap, rinse and dry.

Adults and children 2 years of age and older: Apply to affected area. Repeat as necessary.

Children under 2 years of age: Consult a doctor

Patch test recommended on sensitive skin.

Indications and Use

Temporarily relieves pain and itch associated with sunburn, windburn and chapped skin.
Helps promote healing of minor burns and skin irritations.

Purpose

Temporarily relieves pain and itch associated with sunburn, windburn and chapped skin.
Helps promote healing of minor burns and skin irritations.

Warning

For external use only.  Avoid contact with eyes.

Do not use

Do not use on broken skin. Do not use if hypersensitive to any ingredients in this product.
Breast-feeding women shoud ot apply to breast area.

Ask doctor

Ask a doctor before use in case of deep cuts or puncture wounds, animal bites or serious burns.

Pregnancy or breast feeding

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

Keep out of reach children

Keep out of reach of children.

Overdose

If swallowed, seek meidcal help or contact a Poison Control Center immediately.

LBN21825197.A01 Z Califlora Gel 2.75 oz.jpg

CALIFLORA 
calendula officinalis gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-5190
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 78 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WITCH HAZEL (UNII: 101I4J0U34)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-5190-81 in 1 CARTON01/01/200603/31/2025
178 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:53499-5190-41 in 1 CARTON01/01/200603/31/2025
228 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/01/200603/31/2025
Labeler - Schwabe North America, Inc (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe Mexico, S.A. de C.V.812805901manufacture(53499-5190)

Revised: 5/2022
Document Id: b668a8ea-7d81-4d83-b3e4-ca4f5d2352e7
Set id: 6b4e85c7-b33e-4331-8981-8679b0518bab
Version: 12
Effective Time: 20220503
 
Schwabe North America, Inc