Drug Facts

Active ingredients

Lidocaine Hydrochloride 0.5%

Purpose

External Analgesic

Uses

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations.

Warnings

For external use only
Avoidcontact with eyes
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again with a few days, discontinue use of this product and consult a doctor.

Do not use

in large quantities, particularly over raw surfaces or blistered areas.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

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: Consult a doctor.

Other information

Store between 68°F to 77°F (20°C to 25°). May stain some fabrics or surfaces

Inactive ingredients

Water, Aloe Barbadensis Leaf Extract, Glycerin, Sodium Hydroxide, Propylene Glycol, Glyceryl Acrylate/Acrylic Acid Copolymer, Carbomer, Phenoxyethanol, Polysorbate 20, Caprylyl Glycol, Allantoin, Panthenol, Citrus Limon (Lemon) Peel Extract, Mentha Viridis (Spearmint) Leaf Oil, Symphytum Officinale (Comfrey) Leaf Extract, Tocopheryl Acetate, 1,2-Hexanediol, Ethylhexylglycerin, Blue 1, Yellow 5.

Package Labeling:

Label2

CARING MILL LIDOCAINE ALOE GEL BURN AND PAIN RELIEF
lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81522-953
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALLANTOIN (UNII: 344S277G0Z)
PANTHENOL (UNII: WV9CM0O67Z)
LEMON PEEL (UNII: 72O054U628)
SPEARMINT OIL (UNII: C3M81465G5)
SYMPHYTUM X UPLANDICUM LEAF (UNII: D05HXK6R3G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81522-953-01	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/20/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	01/20/2024

Labeler - FSA Store Inc. (049283340)

Caring mill Lidocaine Aloe Gel Burn and Pain Relief