tattoo cream by Shenzhen Gaoye E-commerce Co., Ltd TATTOO CREAM cream

tattoo cream by

Drug Labeling and Warnings

tattoo cream by is a Otc medication manufactured, distributed, or labeled by Shenzhen Gaoye E-commerce Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Lidocaine 4%

Purpose

External Analgesic

Use

For temporary relief of local and anorectal discomfort associated with anorectal discomfort or inflammation

Warnings

For External Use Only

Pregnant or breastfeeding, ask a health professional before use.

In case of accidental overdose, contact a doctor or Poison Control Center immediately.

Seal is broken or missing.

Do not use

Pregnant or breastfeeding, ask a health professional before use.

In case of accidental overdose, contact a doctor or Poison Control Center immediately.

Seal is broken or missing.

WHEN USING

Do not exceed the recommended daily dosage unless directed by a doctor. Certain persons can develop allergic

reactions to ingredients in this product. Do not put this product into the rectum by using fingers or any medical

device or applicator.

STOP USE

The symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

KEEP OUT OF REACH OF CHILDREN

In case of accidental ingestion, seek medical attention immediately.

Directions

Perform a patch test on the back of your hand before using it to check for skin

sensitivity.When practical, cleanse the affected area with mild soap and warm water and

rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before

application of this product.

Apply up to 2 times a day.

Other information

Keep away from direct sunlight or heat

Store in room temperature (59-860F / 15-300C)

Inactive ingredients

WATER PROPYLENE GLYCOL, CARBOMER, GLYCERIN, DISODIUM EDTA. HYDROXY-ACETOPHENONE

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

TATTOO CREAM 
tattoo cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84322-004
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
3'-HYDROXYACETOPHENONE (UNII: UV3GO1D90J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84322-004-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	07/29/2024

Labeler - Shenzhen Gaoye E-commerce Co., Ltd (412499698)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Gaoye E-commerce Co., Ltd		412499698	manufacture(84322-004)