D-89-1 EARDROPS- plantago major, umbilicus rupestris, lobelia inflata, matricaria chamomilla, aloe vera leaf, calendula arvensis whole, and st. johns wort solution
DNA Labs, 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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D-89-1 Eardrops

NDC 58264-0162-1

ACTIVE INGREDIENTS

Plantago Major 1X, Cotyledon Umbilicus 1X, Lobelia Inflata 1X, Chamomilla 1X, Aloe Vera 1X, Calendula 1X, Hypericum 1X

OTHER INGREDIENTS

Olive oil, garlic oil, mullein oil.

INDICATIONS

Ear pain.

DIRECTIONS

5-10 drops directly into the ear canal as needed or as directed by a health care professional. May also be applied to a cotton ball and inserted into the ear canal. Do not touch dropper to the ear canal.

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

PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label

DYNAMIC
NUTRITIONAL
ASSOCIATES, INC.

D-89-1
EAR DROPS

1 FL. OZ.

D-89-1 EARDROPS
plantago major, umbilicus rupestris, lobelia inflata, matricaria chamomilla, aloe vera leaf, calendula arvensis whole, and st. johns wort solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58264-0162
Route of Administration	AURICULAR (OTIC)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	1 [hp_X] in 1 mL
UMBILICUS RUPESTRIS (UNII: X68TXR7V4Y) (UMBILICUS RUPESTRIS - UNII:X68TXR7V4Y)	UMBILICUS RUPESTRIS	1 [hp_X] in 1 mL
LOBELIA INFLATA (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U)	LOBELIA INFLATA	1 [hp_X] in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	1 [hp_X] in 1 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X)	ALOE VERA LEAF	1 [hp_X] in 1 mL
CALENDULA ARVENSIS WHOLE (UNII: 5PM50140E4) (CALENDULA ARVENSIS WHOLE - UNII:5PM50140E4)	CALENDULA ARVENSIS WHOLE	1 [hp_X] in 1 mL
ST. JOHN'S WORT (UNII: UFH8805FKA) (ST. JOHN'S WORT - UNII:UFH8805FKA)	ST. JOHN'S WORT	1 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
OLIVE OIL (UNII: 6UYK2W1W1E)
GARLIC OIL (UNII: 4WG8U28833)
VERBASCUM DENSIFLORUM WHOLE (UNII: FH9G6709EL)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58264-0162-1	29.57 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/01/1990

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/01/1990	11/22/2022

Labeler - DNA Labs, Inc. (031784339)

Revised: 11/2022

Document Id: ee19aa77-1c2a-2036-e053-2a95a90a18ab

Set id: 9a48e4fb-8d52-423c-9764-68d42a574aed

Version: 3

Effective Time: 20221122

DNA Labs, Inc.