DCH PAIN RELIEF- lidocaine hcl 4% cream

DCH Pain Relief by

Drug Labeling and Warnings

DCH Pain Relief by is a Otc medication manufactured, distributed, or labeled by Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine HCl 4%

PURPOSE

Topical Analgesic

DOSAGE & ADMINISTRATION

Temporarily relieves minor pain.

WARNINGS

For external use only.

Do not use on large areas of the body or on cut, irritated, or swollen skin, on puncture wounds, for more than one week without consulting a doctor.

When using this product use only as directed. Read and follow directions on this carton, avoid contact with eyes and mucous membranes, do not apply to wounds or damaged, broken, or irritated skin, do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use, do not use at the same time as other topical analgesics, a transient burning sensation may occur upon application but generally disappears in several days, avoid applying into skin folds.

Stop use and ask a doctor if the condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days or clear up and occur again within a few days, you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

KEEP OUT OF REACH OF CHILDREN

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

INDICATIONS & USAGE

Adults and children over 12 years: apply a thin layer to the affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period. AFTER APPLYING, WASH HANDS WITH SOAP AND WATER.

Children under 12 years or younger: ask a doctor.

INACTIVE INGREDIENT

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol Denat., Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Methylparaben, Steareth-21, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DCH PAIN RELIEF 
lidocaine hcl 4% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-361
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
STEARETH-21 (UNII: 53J3F32P58)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)
DIMETHICONE 200 (UNII: RGS4T2AS00)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72839-361-02	76.5 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/10/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/10/2021

Labeler - Derma Care Research Labs, LLC (116817470)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(72839-361)