Hemporrhoid by Renu Laboratories, Inc. HEMPORRHOID CREAM

Hemporrhoid by

Drug Labeling and Warnings

Hemporrhoid by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEMPORRHOID- lidocaine hcl cream 
Renu Laboratories, 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.

----------

HEMPORRHOID CREAM

Hemorrhoidal Cream

Lidocaine HCl 5%

Topical Anesthetic

Uses

For the temporary relief of

• Pain
• Itching
• Burning associated with inflamed hemorrhoidal tissues

For external use only

When using this product

• Keep out of eyes. Rinse with water to remove. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if conditions worsen, or, if symptoms persist for more than 7 days, or clear up and occur again within a few days. Discontinue use of this product and consult a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

If pregnant or breast-feeding, ask a health professional before use.

Directions:

Adults and children 2 years of age and older: apply to affected area not more than 3 - 4 times daily.

Children under 2 years of age: Consult a doctor.

Other information: Store between 58 - 87° F

Protect from freezing, direct heat or sunlight.

Questions? www.marswellness.com

Mars Wellness

Lakewood, NJ 08701

INGREDIENTS: Capryl Glycol, Caprylic / Capric Triglyceride, Cetearyl Alcohol, Deionized Water, Emulsifying Wax NF, Ethylhexylglycerin, Glycerin, Hemp Extract with proprietary Terpene blend: (Beta Caryophyllene, Humulene, Limonene, Myrcene, Linalool, Nerolidol, Beta Pinene, Alpha Pinene, Eucalyptol), Hexylene Glycol, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Stearic Acid, Tetrasodium EDTA, Tocopherol.

HEMPORRHOID TUBE ART

HEMPORRHOID 
lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-540
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	1.4 g  in 28 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
TOCOPHEROL (UNII: R0ZB2556P8)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
JOJOBA OIL (UNII: 724GKU717M)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CARYOPHYLLENE (UNII: BHW853AU9H)
.BETA.-PINENE (UNII: 4MS8VHZ1HJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WHITE WAX (UNII: 7G1J5DA97F)
HUMULENE (UNII: 54W56MD2WD)
MYRCENE (UNII: 3M39CZS25B)
LINALOOL, (+)- (UNII: F4VNO44C09)
EDETATE SODIUM (UNII: MP1J8420LU)
CANNABIDIOL (UNII: 19GBJ60SN5)
EUCALYPTOL (UNII: RV6J6604TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
.ALPHA.-PINENE (UNII: JPF3YI7O34)
NEROLIDOL (UNII: QR6IP857S6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-540-01	28 g in 1 TUBE; Type 0: Not a Combination Product	07/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	07/28/2020	07/28/2020

Labeler - Renu Laboratories, Inc. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(76348-540)

Revised: 11/2020

Document Id: b4defc61-37ef-5cd0-e053-2a95a90ab228

34390-5

Set id: ab6f128a-a5a5-7ba8-e053-2a95a90a87d8

Version: 2

Effective Time: 20201124