Califlora Calendula Gel: Homeopathic Product Information

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.

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 ot 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.

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CALIFLORA CALENDULA GEL
calendula officinalis flowering top gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68466-0007
Route of Administration TOPICAL, TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X] in 78 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE C
ALCOHOL
WATER
sodium hydroxide
WITCH HAZEL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68466-0007-8 1 TUBE in 1 CARTON contains a TUBE
1 78 g in 1 TUBE This package is contained within the CARTON (68466-0007-8)
2 NDC:68466-0007-4 1 TUBE in 1 CARTON contains a TUBE
2 28 g in 1 TUBE This package is contained within the CARTON (68466-0007-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 01/01/2006
Labeler — Schwabe Mexico S.A. de D.V (812805901)
Establishment
Name Address ID/FEI Operations
Schwabe Mexico S.A. de D.V 812805901 manufacture (68466-0007)

Revised: 09/2021 Schwabe Mexico S.A. de D.V

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