SILENT NIGHTS- aconitum napellus, arsenicum album, avena sativa, belladonna, camphora, cinchona officinalis, coffea cruda, cypripedium pubescens, hyoscyamus niger, passiflora incarnata, pulsatilla, valeriana officinalis patch

Silent Nights by

Drug Labeling and Warnings

Silent Nights by is a Homeopathic medication manufactured, distributed, or labeled by Lifewave, Inc., King Bio. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

DIRECTIONS:  Place one patch on the body, using one of the locations shown in our instructions or the location of your choice.

INACTIVE INGREDIENT

Water, glycerol, citric acid, potassium sorbate, carnitine

WARNINGS

WARNINGS:  Remove immediately if you feel discomfort or skin irritation occurs.  Do not reuse patch once removed from the skin.
For external use only. Do not ingest.  Do not use more than one set of patches at a time on the body.  Do not use on wounds or
damaged skin.  Ask a health professional before using if you have a health condition.

INDICATIONS & USAGE

For the stimulation of acupuncture points

ACTIVE INGREDIENT

Aconitum Napellus, Arsenicum Album, Avena Sativa, Belladonna, Camphora, Cinchona Officinalis, Coffea Cruda, Cypripedium Pubescens, Hyoscyamus Niger, Passiflora Incarnata, Pulsatilla, Valeriana Officinalis

PURPOSE

For the stimulation of acupuncture points.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PREGNANCY OR BREAST FEEDING

Do not use if pregnant or nursing.

Principal Display Panel

Homeopathic

silent nights

For the stimulation of acupuncture points

30

PATCHES
Made in the USA

INGREDIENTS AND APPEARANCE

SILENT NIGHTS  
aconitum napellus, arsenicum album, avena sativa, belladonna, camphora, cinchona officinalis, coffea cruda, cypripedium pubescens, hyoscyamus niger, passiflora incarnata, pulsatilla, valeriana officinalis patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76335-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	10 [hp_X]
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	10 [hp_X]
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	10 [hp_X]
BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI)	BELLADONNA LEAF	10 [hp_X]
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	10 [hp_X]
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	10 [hp_X]
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	10 [hp_X]
CYPRIPEDIUM PARVIFOLUM ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFOLUM ROOT - UNII:21Y9GZ1LZA)	CYPRIPEDIUM PARVIFOLUM ROOT	10 [hp_X]
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3)	HYOSCYAMUS NIGER	10 [hp_X]
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z)	PASSIFLORA INCARNATA FLOWER	10 [hp_X]
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	10 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	10 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CARNITINE (UNII: S7UI8SM58A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76335-002-30	30 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/31/2009

Labeler - Lifewave, Inc. (965548345)

Registrant - Lifewave, Inc. (965548345)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio		617901350	manufacture(76335-002)

Establishment
Name	Address	ID/FEI	Business Operations
Lifewave, Inc.		965548345	manufacture(76335-002)