Label: CALIFLORA CALENDULA GEL- calendula officinalis flowering top gel
- NDC Code(s): 68466-0007-4, 68466-0007-8
- Packager: Schwabe Mexico S.A. de D.V
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated May 3, 2022
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- Official Label (Printer Friendly)
- Active Ingredient
- Inactive Ingredient
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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
- Purpose
- Warning
- Do not use
- Ask a doctor
- Pregnancy or breast feeding
- Keep out of reach of children.
- Overdose
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CALIFLORA CALENDULA GEL
calendula officinalis flowering top gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68466-0007 Route of Administration TOPICAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X] in 78 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) sodium hydroxide (UNII: 55X04QC32I) WITCH HAZEL (UNII: 101I4J0U34) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68466-0007-8 1 in 1 CARTON 01/01/2006 03/31/2025 1 78 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68466-0007-4 1 in 1 CARTON 01/01/2006 07/31/2023 2 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2006 03/31/2025 Labeler - Schwabe Mexico S.A. de D.V (812805901) Establishment Name Address ID/FEI Business Operations Schwabe Mexico S.A. de D.V 812805901 manufacture(68466-0007)