SUNHEAL TATTOO NUMBING CREAM cream

SUNHEAL Tattoo Numbing Cream by

Drug Labeling and Warnings

SUNHEAL Tattoo Numbing Cream by is a Otc medication manufactured, distributed, or labeled by IBP CORP CO. LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 5%

Purpose

For the temporary relief of local itching, soreness and burning of tattoos, piercing and waxing.

Use

Tattoo Numbing Cream for tattoos, piercing and waxing, provides deep numbness for up to 7 hours of relief itching, soreness and burning of them.

Warnings

For external use only.
Keep out of reach of children.
If swallowed, get medical help.
Do not use if allergic to any ingredients.
If pregnant or breastfeeding ask a health professional before use.

Do not use

Allergic reaction occurs to ingredients in this product.

When Using

Do not get into the eyes.
Do not exceed recommended dosage unless directed by a doctor.
Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop Use

Condition worsens or does not improve within 7 days.
Allergic reaction occurs to ingredients in this product.
Symptom being treated does not subside or if redness, irritation.

Ask Doctor

Swelling, pain or other symptoms develop or increase.
Symptoms clear up and return within a few days.

Keep Oot Of Reach Of Children

If swallowed, get medical help or contact a poison control center right away.

Directions

1.Cleanse targeted skin area, pat dry.
2.Apply a thick layer (1mm) onto targeted skin area.
3.Wrap the treated area tightly with plastic wrap and remain for 60 minutes for peak numbing. Conduct a patch test to assess your best numbing timing.
4.Remove the plastic wrap and wipe away residue, then begin treatment.

Other information

Store in a cool, dry place away from direct sunlight.

Inactive ingredients

Aqua, Glycerin, Isopropyl Palmitate, Aloe Barbadensis Leaf Extract,
Helianthus Annuus (Sunflower) Seed Oil, Glyceryl Stearate,
Pentylene Glycol, Cetyl Alcohol, Piper Methysticum Leaf/Root/Stem Extract, Peg-100 Stearate, Tocopheryl Acetate, Panthenol, Camellia Japonica Flower Extract,
Zingiber Officinale (Ginger) Root Extract, Commiphora Myrrha Extract, Camphor, Menthol, Lecithin, Phenoxyethanol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNHEAL TATTOO NUMBING CREAM 
sunheal tattoo numbing cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83871-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GINGER (UNII: C5529G5JPQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
MACROPIPER METHYSTICUM ROOT (UNII: BOW48C81XP)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PANTHENOL (UNII: WV9CM0O67Z)
MENTHOL (UNII: L7T10EIP3A)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYOXYL 100 STEARATE (UNII: YD01N1999R)
COMMIPHORA MYRRHA WHOLE (UNII: UU81N77RI7)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CAMELLIA JAPONICA FLOWER (UNII: KUB8101TNF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83871-001-01	45 g in 1 BOTTLE; Type 0: Not a Combination Product	12/18/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/18/2023

Labeler - IBP CORP CO. LTD. (692424700)

Establishment
Name	Address	ID/FEI	Business Operations
IBP CORP CO. LTD.		692424700	label(83871-001) , manufacture(83871-001)