Active Ingredients
Lidocaine 5%
Adellina Tattoo Numbing Cream Cream, Augmented
FDA Label NDC 60771-0010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Haishi Biological Technology Co., Ltd. for the product Adellina Tattoo Numbing Cream (NDC 60771-0010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, use, for external use only., otc - stop use, otc - do not use, otc - when using, keep out of reach of children, dosage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
For the physical or local anesthesia associated with tattoo
For External Use Only.
Avoid contact with the eyes Keep away from heat or flame. Do not use in large quantities, particularly over raw surfaces or blistered areas.
Otc - Stop Use
Stop use and ask a doctor if redness, irritation, swelling, pain, or other symptoms occurs,or If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
Otc - Do Not Use
Do not use this product if Pregnant or breastfeeding, ask a health professional before use. In case of accidental overdose, get medical help or contact the Poison Control Center immediately. Seal is broken or missing.
Otc - 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 finger.
Keep Out Of Reach Of Children
In case of accidental ingestion, seek medical help immediately.
Dosage
Squeeze out an appropriate amount of product and spread evenly on skin
Inactive Ingredients
AQUA 71.3%
PROPYLENE 5%
CARBOMER 0.25%
GLYCERIN 5%
DISODIUM EDTA 0.05%
HYDROXYACETOPHENONE 0.4%
1,2-HEXANEDIOL 5%
MENTHA ARVENSIS LEAF EXTRACT 2%
CHRYSANTHELLUM INDICUM EXTRACT 2%
PORTULACA OLERACEA EXTRACT 2%
PEG-40 HYDROGENATED CASTOR OIL 2%
Package Label.Principal Display Panel
Label. (01)
* Please review the disclaimer below.
