FIRST AID BEAUTY FAB ULTRA REPAIR INTENSE HYDRATION SKIN PROTECTANT WINTER CITRUS- colloidal oatmeal cream

First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Winter Citrus by

Drug Labeling and Warnings

First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Winter Citrus by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Colloidal Oatmeal 0.5%

Purpose

Skin Protectant

Uses

• Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, poison ivy, oak or sumac, insect bites

Warnings

For external use only.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not get into eyes.

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days

Directions

Apply as needed

INACTIVE INGREDIENT

Water, stearic acid, glycerin, c12-15 alkyl benzoate, caprylic/- capric triglyceride, glyceryl stearate, glyceryl stearate SE, cetearyl alcohol, butyrospermum parkii (shea) butter, dimethicone, squalane, phenoxyethanol, caprylyl glycol, xanthan gum, citrus paradisi, citrus reticulata (tangerine) peel oil, orange terpenes, allantoin, sodium hydroxide, tetrasodium EDTA, chrysanthemum parthenium (feverfew) extract, camellia sinensis leaf extract, glycyrrhiza glabra (licorice) root extract, ceramide NP

Questions:

888-FAB-3063

SPL UNCLASSIFIED SECTION

MADE IN USA

FIRST AID BEAUTY LTD

NEWTON, MA 02458

WWW.FIRSTAIDBEAUTY.COM

PRINCIPAL DISPLAY PANEL - 396.8 g (14 oz)

First Aid Beauty

FAB

Ultra Repair® Cream

Intense Hydration

Skin Protectant Colloidal Oatmeal

Winter Citrus

Net Wt. 396.8 g (14 oz)

INGREDIENTS AND APPEARANCE

FIRST AID BEAUTY FAB ULTRA REPAIR INTENSE HYDRATION SKIN PROTECTANT WINTER CITRUS 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84126-049
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ORANGE TERPENES (UNII: 9J3RG7FX7S)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
SQUALANE (UNII: GW89575KF9)
DIMETHICONE (UNII: 92RU3N3Y1O)
TETRASODIUM EDTA (UNII: MP1J8420LU)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
GLYCYRRHIZA GLABRA (LICORICE) ROOT (UNII: 2788Z9758H)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALLANTOIN (UNII: 344S277G0Z)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)
CERAMIDE NP (UNII: 4370DF050B)
TANACETUM PARTHENIUM WHOLE (UNII: 6GE7Z0761K)
MANDARIN OIL (UNII: NJO720F72R)
CITRUS PARADISI (GRAPEFRUIT) PEEL OIL (UNII: YR377U58W9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-049-39	396.8 g in 1 JAR; Type 0: Not a Combination Product	10/01/2024
2	NDC: 84126-049-01	2 in 1 PACKAGE	10/01/2024
2		396.8 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	10/01/2024

Labeler - The Procter & Gamble Manufacturing Company (004238200)