SELECT BRAND HEMORRHOID- glycerin, petrolatum, phenylephrine hydrochloride, pramoxine hydrochloride cream 
L&R Distributors, 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.

----------

Drug Facts

Active ingredients

Glycerin 14.4%

Petrolatum 15%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

Purposes

Protectant

Protectant

Vasoconstrictor

Local anesthetic

Uses

Warnings

For external use only

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • bleeding occurs
  • condition gets worse or does not improve within 7 days

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

cetearyl alcohol, cetyl alcohol, glycerol monostearate, mineral oil, peg 40 castor oil, propylene glycol, purified water, stearyl alcohol, tocopheryl acetate (Vitamin E)

Principal Display Panel - 1oz Carton Label

NDC 15127-590-00

A medicated cream for local application as an aid
in the relief of the discomfort due to rectal irritation.

select brand®

the lower price name brand

HEMORRHOIDAL
CREAM

MAXIMUM STRENGTH

*Compare to the active ingredients in
Preparation H® Maximum Strength Cream

Net Wt. 1 oz (28g)

Principal Display Panel - 1oz Carton Label
SELECT BRAND HEMORRHOID 
glycerin, petrolatum, phenylephrine hydrochloride, pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-590
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin144 mg  in 1 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum150 mg  in 1 g
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride2.5 mg  in 1 g
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Aloe Vera Leaf (UNII: ZY81Z83H0X) 10 mg  in 1 g
Cetostearyl Alcohol (UNII: 2DMT128M1S) 10 mg  in 1 g
Cetyl Alcohol (UNII: 936JST6JCN) 20 mg  in 1 g
Glyceryl Monostearate (UNII: 230OU9XXE4) 22 mg  in 1 g
Mineral Oil (UNII: T5L8T28FGP) 69 mg  in 1 g
Peg-40 Castor Oil (UNII: 4ERD2076EF) 10 mg  in 1 g
Water (UNII: 059QF0KO0R) 500.5 mg  in 1 g
Propylene Glycol (UNII: 6DC9Q167V3) 20 mg  in 1 g
Stearyl Alcohol (UNII: 2KR89I4H1Y) 20 mg  in 1 g
.ALPHA.-Tocopherol Acetate (UNII: 9E8X80D2L0) 10 mg  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-590-001 in 1 CARTON03/01/2014
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/01/2014
Labeler - L&R Distributors, Inc. (012578514)
Establishment
NameAddressID/FEIBusiness Operations
Natural Essentials947484713MANUFACTURE(15127-590)

Revised: 1/2018
Document Id: e9531111-f98c-495e-84a3-9b7275e93edb
Set id: 191cc88d-0f8d-4090-95aa-879de8dc6657
Version: 2
Effective Time: 20180124
 
L&R Distributors, Inc.