CALENDULA OFF.- calendula officinalis flowering top ointment

Calendula Off. by

Drug Labeling and Warnings

Calendula Off. by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's, Standard Homeopathic Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Minor Skin Irritations

Warnings

For External Use Only.

Keep this and all medicines out of the reach of children.

If symptoms persist for more than seven days or worsen, consults a licensed health care professional.

Do not use if tamper evident seal is broken or missing.

Directions

Wash affected area with lukewarm water and apply freely as needed, or as recommended by a licensed health care provider.

INACTIVE INGREDIENT

In a base of Petrolatum USP, with 5% Lanolin USP.

QUESTIONS

800/624-9659

ACTIVE INGREDIENT

CALENDULA OFFICINALIS 1x

PURPOSE

For the temporary symptomatic relief of skin irritations due to sunburn, windburn and chafing or diaper rash. Promotes healing of minor cuts and abrasions of the skin.

PRINCIPAL DISPLAY PANEL

NDC: 54973-2052-09

Hyland's™

HOMEOPATHIC

Calendula

Off. 1x

Minor Skin Irritations

Homeopathic Ointment

13.5 OZ./405 GM.

INGREDIENTS AND APPEARANCE

CALENDULA OFF. 
calendula officinalis flowering top ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-2052
Route of Administration	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 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	yellow (Greenish-yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-2052-9	405 g in 1 JAR; Type 0: Not a Combination Product	02/17/1997
2	NDC: 54973-2052-3	105 g in 1 JAR; Type 0: Not a Combination Product	02/17/1997
3	NDC: 54973-2052-1	30 g in 1 TUBE; Type 0: Not a Combination Product	02/17/1997

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/17/1997

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-2052) , pack(54973-2052) , label(54973-2052)