HEAL AND RESCUE BUNION PAIN RELIEF- lidocaine hcl, menthol gel

Heal and Rescue Bunion Pain Relief by

Drug Labeling and Warnings

Heal and Rescue Bunion Pain Relief by is a Otc medication manufactured, distributed, or labeled by Rooftop Consumer Health, Inc, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine HCl 4%, Menthol 1%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

Temporarily relieves minor pain.

WARNINGS

For external use only.Flammable. Keep away from fire or flame. Do not use if you have an allergic reaction to Lidocaine HCl or other local anesthetics, on large areas of the body or on cut, irritated, blistered, or swollen skin, puncture wounds, for more than one week without consulting a doctor.

When using this product use only as directed. Read and follow all directions and warnings on this carton, avoid contact with eyes and mucous membranes, rare cases of serious burns have been reported with products of this type, 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, 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 condition worsens, severe burning sensation, redness, rash or 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.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Adults and children 12 years and older: apply to the affected area, not more than 6 to 8 hours. Do not exceed 3 applications in a 24-hour period. Massage into painful area until thoroughly absorbed into the skin. AFTER APPLYING WASH HANDS WITH SOAP ANDWATER. Children under 12 years of age: 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, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Methylparaben, Polysorbate 60, Steareth-21, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEAL AND RESCUE BUNION PAIN RELIEF 
lidocaine hcl, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29784-410
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISOHEXADECANE (UNII: 918X1OUF1E)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
STEARETH-21 (UNII: 53J3F32P58)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
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)
ALCOHOL (UNII: 3K9958V90M)
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)
DIMETHICONE 200 (UNII: RGS4T2AS00)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29784-410-02	1 in 1 CARTON	03/02/2026
1		70.9 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/02/2026

Labeler - Rooftop Consumer Health, Inc (107570900)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(29784-410)