DG HEALTH MEDICATED ANTI-ITCH  ANALGESIC- menthol, unspecified form and pramoxine hydrochloride cream 
DOLGENCORP, LLC

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.

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DG™ Health Medicated Anti-Itch Cream
Topical Analgesic

Drug Facts

Active ingredientsPurpose
Menthol 1%Anti-itch, pain relief
Pramoxine hydrochloride 1%Anti-itch, pain relief

Use

For temporary relief of pain and itching associated with minor skin irritations, minor burns, minor cuts, sunburns, scrapes, insect bites, and rashes due to poison ivy, poison oak, or poison sumac

Warnings

For external use only.

Avoid contact with eyes and nose.

Not for prolonged use.

Do not use

  • on large areas of the body

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness, irritation, swelling, or pain develops, persists, or increases

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: 800-222-1222.

Directions

Other information

Inactive ingredients

aloe barbadensis leaf juice, carbomer, cetearyl alcohol, DMDM hydantoin, glycerin, polysorbate 60, propylene glycol, purified water, triethanolamine

Questions or comments?

888-309-9030

DISTRIBUTED BY OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

DG™| health

Compare to the active ingredients
of Gold Bond® Medicated
Anti-Itch Cream*

Medicated
Anti-Itch Cream
Menthol, Pramoxine Hydrochloride

NET WT 1 OZ (28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
DG HEALTH MEDICATED ANTI-ITCH  ANALGESIC
menthol, unspecified form and pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-330
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form10 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)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-330-241 in 1 CARTON01/02/2008
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 not finalpart34701/02/2008
Labeler - DOLGENCORP, LLC (068331990)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(55910-330)

Revised: 8/2020
Document Id: 611ebafc-c024-4a34-8310-67055526fa41
Set id: bf0234f3-0dfb-4e0c-a321-9829137526c3
Version: 2
Effective Time: 20200825
 
DOLGENCORP, LLC