CALIFLORA CALENDULA GEL- calendula officinalis flowering top gel 
Schwabe Mexico S.A. de D.V

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 Calendula Gel

Active Ingredient

Contains 10% CALENDULA OFFICINALIS 1X

Inactive Ingredient

CARBOMER 

ETHYL ALCOHOL

PURIFIED WATER

SODIUM HYDROXIDE

WITCH HAZEL DISTILLATE

Dosage & Administration 

Directions:

Apply thin layer to affected area. 

For best results, use promptly after injury or tramua 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 & Usage

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

Ask a 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 of children.

Keep out of the reach of children.

Overdose

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

LBN21825197.A01-Califlora Gel.jpg

CALIFLORA CALENDULA GEL 
calendula officinalis flowering top gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68466-0007
Route of AdministrationTOPICAL, TOPICAL
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:68466-0007-81 in 1 CARTON01/01/200603/31/2025
178 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:68466-0007-41 in 1 CARTON01/01/200607/31/2023
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 Mexico S.A. de D.V (812805901)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe Mexico S.A. de D.V812805901manufacture(68466-0007)

Revised: 5/2022
Document Id: d2c4b78b-c7bb-4f92-b2f4-5ef151e1e28c
Set id: 406617f2-0b6c-4452-90f5-611343b39dca
Version: 8
Effective Time: 20220503
 
Schwabe Mexico S.A. de D.V