Dg™ Health Medicated Anti-itch Cream

Dg™ Health Medicated Anti-itch Cream
SPL v2
SPL
SPL Set ID bf0234f3-0dfb-4e0c-a321-9829137526c3
Route
TOPICAL
Published
Effective Date 2020-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (10 mg) Pramoxine
Inactive Ingredients
Aloe Vera Leaf Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Dmdm Hydantoin Cetostearyl Alcohol Polysorbate 60 Glycerin Propylene Glycol Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2008-01-02

Description

Drug Facts


Medication Information

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 53414-9

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

Section 55105-1
Active ingredients Purpose
Menthol 1% Anti-itch, pain relief
Pramoxine hydrochloride 1% Anti-itch, pain relief
Warnings

For external use only.

Avoid contact with eyes and nose.

Not for prolonged use.

Directions
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
Do Not Use
  • on large areas of the body
Other Information
  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.
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

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
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)


Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients Purpose
Menthol 1% Anti-itch, pain relief
Pramoxine hydrochloride 1% Anti-itch, pain relief
Warnings

For external use only.

Avoid contact with eyes and nose.

Not for prolonged use.

Directions
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
Do Not Use (Do not use)
  • on large areas of the body
Other Information (Other information)
  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

888-309-9030

Stop Use and Ask A Doctor If (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
Principal Display Panel 28 G Tube Carton (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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)