ROYAL LABS HEMP RECOVER- royal labs hemp recover cream
Royal Labs Natural Cosmetics, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Royal Labs Hemp Recover

Dosage & Administration Section

Dosage & Adminstration Section

Indications & Usage Section

Indictations & Usage Section

Active Ingredient Section

Histamine Dihydrochloride 0.05%

Inactive Ingredient Section

OTC-Keep out of reach of children section

OTC- Purpose Section

Warnings

For external use only.

Royal Labs Hemp Recover

ROYAL LABS HEMP RECOVER
royal labs hemp recover cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69580-400
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	0.05 mg in 100 mg

Ingredient Name	Strength
Inactive Ingredients
SUNFLOWER OIL (UNII: 3W1JG795YI)	1 mg in 100 mg

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69580-400-10	118 mg in 1 JAR; Type 0: Not a Combination Product	12/17/2019
2	NDC:69580-400-20	3785 mg in 1 PAIL; Type 0: Not a Combination Product	12/17/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/17/2019	12/17/2021

Labeler - Royal Labs Natural Cosmetics, Inc (197478480)

Registrant - Royal Labs Natural Cosmetics, Inc. (197478480)

Name	Address	ID/FEI	Business Operations
Establishment
Royal Labs Natural Cosmetics, Inc.		197478480	manufacture(69580-400)

Revised: 12/2021

Document Id: d35de102-ab35-6130-e053-2995a90ab9c4

Set id: 99ee9d6e-3791-02a5-e053-2995a90a0c3a

Version: 3

Effective Time: 20211217

Royal Labs Natural Cosmetics, Inc