FDA.reportPublic FDA data

Spot a Spot Exfoliating Acne Solution

Manufacturer
Give Back Beauty, LLC
Effective date
2025-12-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-06-03 17:45:41

Key Label Information#

Active Ingredients And Purpose

Active Ingredient

Safcylic Acid 2%

Purpose

Acne Treatment

Uses

Uses

• For the treatment of acne

Warnings

Warnings

For external use only When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Directions And Dosage

Directions

Clean the skin thoroughly before applying this product Cover the entire affected area with a thin layer one to three times daily Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily it needed or as directed by a doctor If bothersome dryness or peeling occurs, reduce application to once a day or every other day. Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occur, follow the directions stated

Other Label Information

Inactive ingredients

WATER, BUTYLENE GLYCOL, ARGININE, LACTIC ACID, SODIUM BENZOATE, ALLANTOIN, POTASSIUM SORBATE, GLYCOLIC ACID, GLYCERIN, CENTELLA ASIATICA EXTRACT, MALPIGHIA EMARGINATA (ACEROLA) FRUIT EXTRACT

Label Images#

Spot a Spot Exf Sol
Spot a Spot Exf Sol

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85623-10385623-103-05

Ingredients#

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
LACTIC ACID33X04XA5ATIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CENTELLA ASIATICA7M867G6T1UIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALLANTOIN344S277G0ZIACT
GLYCOLIC ACID0WT12SX38SIACT
MALPIGHIA EMARGINATA WHOLE0GE13RK3P1IACT
ARGININE94ZLA3W45FIACT
SODIUM BENZOATEOJ245FE5EUIACT
SALICYLIC ACIDO414PZ4LPZACTIB
GLYCERINPDC6A3C0OXIACT

Complete SPL Sections#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Safcylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

• For the treatment of acne

Warnings

WARNINGS SECTION

For external use only When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the skin thoroughly before applying this product Cover the entire affected area with a thin layer one to three times daily Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily it needed or as directed by a doctor If bothersome dryness or peeling occurs, reduce application to once a day or every other day. Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occur, follow the directions stated

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, BUTYLENE GLYCOL, ARGININE, LACTIC ACID, SODIUM BENZOATE, ALLANTOIN, POTASSIUM SORBATE, GLYCOLIC ACID, GLYCERIN, CENTELLA ASIATICA EXTRACT, MALPIGHIA EMARGINATA (ACEROLA) FRUIT EXTRACT

Source Document#

Source XML