SLEEP STARTER TOPICAL PATCH，Sleep Patch

SLEEP STARTER TOPICAL Patch, Sleep Patch by

Drug Labeling and Warnings

SLEEP STARTER TOPICAL Patch, Sleep Patch by is a Otc medication manufactured, distributed, or labeled by ZheJiang Longmed Medical Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SLEEP STARTER TOPICAL PATCH, SLEEP PATCH- melatonin, valeriana officinalis patch 
ZheJiang Longmed Medical Technology Co., Ltd.

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SLEEP STARTER TOPICAL PATCH，Sleep Patch

Melatonin
Valeriana Officinalis

Sleep Patch

1. For external use only. Avoid contact with eyes, mucous membranes, or brokenskin.
2. Discontinue use immediately and seek medical attention if redness, itching, orother allergic reactions occur.
3. Use with caution when combining with sleep aids or alcohol.
4. Do not apply the patch to facial areas or non-recommended body parts.

KEEP OUT OF REACH OF CHILDREN SECTION

1. Remove the patch from its packaging.
2. Apply it to a dry and hairless area on your body( abdomen, chest, arm,or backarea) and gently press.
3. it can also be cut into the appropriate size for use according to the needs.

1. Apply the patch 30 minutes to 1 hour before bedtime for optimal effectiveness.
2.
Clean the skin thoroughly before application to remove oils or cosmetic residues.
3. lf the edges of the patch lift, gently press to ensure adhesion.

Magnesium
Tryptophan
Humulus Lupulus
5-HTP

SLEEP STARTER TOPICAL PATCH, SLEEP PATCH 
melatonin, valeriana officinalis patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84534-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VALERIANA OFFICINALIS WHOLE (UNII: FP6O7F1X9R) (VALERIANA OFFICINALIS WHOLE - UNII:FP6O7F1X9R)	VALERIANA OFFICINALIS WHOLE	5.12 mg
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	MELATONIN	0.08 mg

Inactive Ingredients
Ingredient Name	Strength
TRYPTOPHAN (UNII: 8DUH1N11BX)
HUMULUS LUPULUS WHOLE (UNII: 912A6Q1N4A)
5-HYDROXYTRYPTOPHAN, DL- (UNII: 9181P3OI6N)
MAGNESIUM (UNII: I38ZP9992A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84534-005-20	20 in 1 BOX; Type 0: Not a Combination Product	04/10/2025	07/09/2025
2	NDC: 84534-005-30	30 in 1 BOX; Type 0: Not a Combination Product	04/10/2025	07/09/2025
3	NDC: 84534-005-40	40 in 1 BOX; Type 0: Not a Combination Product	04/10/2025	07/09/2025
4	NDC: 84534-005-50	50 in 1 BOX; Type 0: Not a Combination Product	04/10/2025	07/09/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	04/10/2025	07/09/2025

Labeler - ZheJiang Longmed Medical Technology Co., Ltd. (554468373)

Establishment
Name	Address	ID/FEI	Business Operations
ZheJiang Longmed Medical Technology Co., Ltd.		554468373	manufacture(84534-005)

Revised: 7/2025

Document Id: 397c3546-0469-ab64-e063-6294a90a6975

34390-5

Set id: 326831ad-b3c6-f702-e063-6394a90a4f6a

Version: 2

Effective Time: 20250709

 

ZheJi